Access Data

NCI Description

NCT00301821-D1-Dataset.csv (outcome) is one of 2 datasets associated with PubMed ID 21673350. This dataset contains information that will allow you to reproduce the baseline characteristics table, time-to-event analyses, and response analysis.

Clinical Trial Title

A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

Trial Summary and Conditions

RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Primary: Assess the efficacy of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP), as measured by 12-month, event-free survival, in patients with previously untreated stage II, III, or IV diffuse large B-cell lymphoma. Assess the use of positron emission tomography (PET) scan routinely early in treatment and after completion of treatment.> Assess the functional response rate (complete response, partial response, or stable disease by CT scan and PET negative) in patients treated with this regimen. Assess the safety of this treatment regimen. Secondary: Correlate laboratory prognostic factors for large cell lymphoma with clinical response to this regimen. OUTLINE: This is a multicenter study. Patients receive epratuzumab IV over 1 hour on day 1, rituximab IV over 4-8 hours on day 1 or days 1 and 2, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 or 2, and oral prednisone on days 1-5 or 2-6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.> After completion of study treatment, patients are followed periodically for up to 5 years. PROJECTED ACCRUAL: A total of 86 patients will be accrued for this study.

Outcome Measures

Primary: Event-free Survival After 12 Months [ Time Frame: From Baseline to 12 months ] Secondary: Overall Survival [ Time Frame: time from study entry to 36 months ] Progression-free Survival (PFS) [ Time Frame: the time from study entry to 36 months ] Overall Response Rate (ORR) [ Time Frame: Baseline to first 6 cycles of treatment ]

NCI Description

NCT00301821-D2-Dataset.csv (events) is one of 2 datasets associated with PubMed ID 21673350. This dataset contains information that will allow you to reproduce the adverse events reported.

Clinical Trial Title

A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

Trial Summary and Conditions

RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Primary: Assess the efficacy of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP), as measured by 12-month, event-free survival, in patients with previously untreated stage II, III, or IV diffuse large B-cell lymphoma. Assess the use of positron emission tomography (PET) scan routinely early in treatment and after completion of treatment.> Assess the functional response rate (complete response, partial response, or stable disease by CT scan and PET negative) in patients treated with this regimen. Assess the safety of this treatment regimen. Secondary: Correlate laboratory prognostic factors for large cell lymphoma with clinical response to this regimen. OUTLINE: This is a multicenter study. Patients receive epratuzumab IV over 1 hour on day 1, rituximab IV over 4-8 hours on day 1 or days 1 and 2, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 or 2, and oral prednisone on days 1-5 or 2-6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.> After completion of study treatment, patients are followed periodically for up to 5 years. PROJECTED ACCRUAL: A total of 86 patients will be accrued for this study.

Outcome Measures

Primary: Event-free Survival After 12 Months [ Time Frame: From Baseline to 12 months ] Secondary: Overall Survival [ Time Frame: time from study entry to 36 months ] Progression-free Survival (PFS) [ Time Frame: the time from study entry to 36 months ] Overall Response Rate (ORR) [ Time Frame: Baseline to first 6 cycles of treatment ]

NCI Description

The dataset NCT00644228-D1-Dataset.csv will allow users to reproduce efficacy analyses included in the aforementioned publication, which included primary and secondary efficacy results evaluating the addition of bortezomib to lenalidomide and low dose dexamethasone induction therapy for the treatment of patients with newly diagnosed multiple myeloma in the SWOG phase III trial, S0777.

Clinical Trial Title

A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients With Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant

Trial Summary and Conditions

This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To compare progression-free survival (PFS) in patients with newly diagnosed myeloma treated with lenalidomide plus low dose dexamethasone versus bortezomib plus lenalidomide and low dose dexamethasone. SECONDARY OBJECTIVES: I. Assess response using the new international response criteria. II. To bank specimens for future translational medicine research. III. Follow patients to assess overall survival and other long-term outcomes stratified by intent to transplant at progression. TERTIARY OBJECTIVES: I. To evaluate custom and genome-wide single nucleotide polymorphisms in correlation with biology, prognosis and outcome for both treatment regimens combined; to verify the findings recently obtained with the custom Bank on a Cure program (BOAC) single nucleotide polymorphism (SNP) chip on Total Therapy 2 (TT2) data with respect to bone disease in the cooperative group setting. II. To use baseline gene expression profiling as a tool to evaluate the biology, prognostic and risk factors, and response to therapy for both treatment regimens combined. To validate John Shaughnessy's 70 gene risk model developed for Total Therapy 2 (TT2) in the cooperative group setting. OUTLINE: INDUCTION THERAPY: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive dexamethasone orally (PO) once daily (QD) on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. In both arms, patients who intend to undergo transplantation at relapse undergo peripheral blood stem cell collection, preferably after course 2.

Outcome Measures

Primary: Progression-free Survival [ Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years ] Secondary: Overall Survival [ Time Frame: Up to 6 years ] Response Rates () [ Time Frame: Up to 6 years ]

NCI Description

The dataset NCT00644228-D2-Dataset.csv will allow users to reproduce safety analyses included in the aforementioned publication, which compared toxicity between bortezomib, lenalidomide and low dose dexamethasone versus lenalidomide and low dose dexamethasone induction therapy for the treatment of patients with newly diagnosed multiple myeloma in the SWOG phase III trial, S0777.

Clinical Trial Title

A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients With Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant

Trial Summary and Conditions

This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To compare progression-free survival (PFS) in patients with newly diagnosed myeloma treated with lenalidomide plus low dose dexamethasone versus bortezomib plus lenalidomide and low dose dexamethasone. SECONDARY OBJECTIVES: I. Assess response using the new international response criteria. II. To bank specimens for future translational medicine research. III. Follow patients to assess overall survival and other long-term outcomes stratified by intent to transplant at progression. TERTIARY OBJECTIVES: I. To evaluate custom and genome-wide single nucleotide polymorphisms in correlation with biology, prognosis and outcome for both treatment regimens combined; to verify the findings recently obtained with the custom Bank on a Cure program (BOAC) single nucleotide polymorphism (SNP) chip on Total Therapy 2 (TT2) data with respect to bone disease in the cooperative group setting. II. To use baseline gene expression profiling as a tool to evaluate the biology, prognostic and risk factors, and response to therapy for both treatment regimens combined. To validate John Shaughnessy's 70 gene risk model developed for Total Therapy 2 (TT2) in the cooperative group setting. OUTLINE: INDUCTION THERAPY: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive dexamethasone orally (PO) once daily (QD) on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. In both arms, patients who intend to undergo transplantation at relapse undergo peripheral blood stem cell collection, preferably after course 2.

Outcome Measures

Primary: Progression-free Survival [ Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years ] Secondary: Overall Survival [ Time Frame: Up to 6 years ] Response Rates () [ Time Frame: Up to 6 years ]

NCI Description

NCT00866918-D1 There is one row for each patient enrolled. The dataset provides the information of consort flow of patient enrollment, baseline characteristics, adverse event status in each course, induction response, RQPCR (molecular) remission status, and primary outcome for the patients on AAML0631 as reported in the manuscript.

Clinical Trial Title

A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients With Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant

Trial Summary and Conditions

This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To compare progression-free survival (PFS) in patients with newly diagnosed myeloma treated with lenalidomide plus low dose dexamethasone versus bortezomib plus lenalidomide and low dose dexamethasone. SECONDARY OBJECTIVES: I. Assess response using the new international response criteria. II. To bank specimens for future translational medicine research. III. Follow patients to assess overall survival and other long-term outcomes stratified by intent to transplant at progression. TERTIARY OBJECTIVES: I. To evaluate custom and genome-wide single nucleotide polymorphisms in correlation with biology, prognosis and outcome for both treatment regimens combined; to verify the findings recently obtained with the custom Bank on a Cure program (BOAC) single nucleotide polymorphism (SNP) chip on Total Therapy 2 (TT2) data with respect to bone disease in the cooperative group setting. II. To use baseline gene expression profiling as a tool to evaluate the biology, prognostic and risk factors, and response to therapy for both treatment regimens combined. To validate John Shaughnessy's 70 gene risk model developed for Total Therapy 2 (TT2) in the cooperative group setting. OUTLINE: INDUCTION THERAPY: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive dexamethasone orally (PO) once daily (QD) on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. In both arms, patients who intend to undergo transplantation at relapse undergo peripheral blood stem cell collection, preferably after course 2.

Outcome Measures

Primary: Progression-free Survival [ Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years ] Secondary: Overall Survival [ Time Frame: Up to 6 years ] Response Rates () [ Time Frame: Up to 6 years ]

NCI Description

NCT00866918-D2 These data provide specific incidence of adverse events in interest. This dataset is necessary to construct Table 3 (Toxicities Reported in >10% of Patients During a Course of Therapy) on the manuscript.

Clinical Trial Title

A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients With Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant

Trial Summary and Conditions

This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To compare progression-free survival (PFS) in patients with newly diagnosed myeloma treated with lenalidomide plus low dose dexamethasone versus bortezomib plus lenalidomide and low dose dexamethasone. SECONDARY OBJECTIVES: I. Assess response using the new international response criteria. II. To bank specimens for future translational medicine research. III. Follow patients to assess overall survival and other long-term outcomes stratified by intent to transplant at progression. TERTIARY OBJECTIVES: I. To evaluate custom and genome-wide single nucleotide polymorphisms in correlation with biology, prognosis and outcome for both treatment regimens combined; to verify the findings recently obtained with the custom Bank on a Cure program (BOAC) single nucleotide polymorphism (SNP) chip on Total Therapy 2 (TT2) data with respect to bone disease in the cooperative group setting. II. To use baseline gene expression profiling as a tool to evaluate the biology, prognostic and risk factors, and response to therapy for both treatment regimens combined. To validate John Shaughnessy's 70 gene risk model developed for Total Therapy 2 (TT2) in the cooperative group setting. OUTLINE: INDUCTION THERAPY: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive dexamethasone orally (PO) once daily (QD) on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. In both arms, patients who intend to undergo transplantation at relapse undergo peripheral blood stem cell collection, preferably after course 2.

Outcome Measures

Primary: Progression-free Survival [ Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years ] Secondary: Overall Survival [ Time Frame: Up to 6 years ] Response Rates () [ Time Frame: Up to 6 years ]

NCI Description

?NCT00379340-D1? is required for recreating the main results of AREN0533 study. Each row corresponds with the results for a single patient. The datasets also provide patient data necessary for recreating the experimental cohorts as well as characteristics of the initial disease, treatment, and outcomes.

Clinical Trial Title

Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

Trial Summary and Conditions

This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Favorable Histology Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. Determine the 4-year event-free survival (EFS) of patients with stage IV favorable histology (FH) Wilms' tumor with pulmonary metastases only who have complete resolution of pulmonary lesions without whole lung irradiation treated with DD4A chemotherapy comprising vincristine, dactinomycin, and doxorubicin hydrochloride. II. Determine the 4-year EFS of these patients who do not have resolution of pulmonary metastases by week 6 treated with the addition of cyclophosphamide and etoposide to a modified-regimen DD4A (regimen M). III. Determine the 4-year EFS of patients with stage III or IV FH Wilms' tumor with loss of heterozygosity for chromosomes 1p and 16q treated with regimen M. SECONDARY OBJECTIVES: I. Correlate the burden of pulmonary metastatic disease with outcome in patients with stage IV FH Wilms' tumor. OUTLINE: This is a multicenter study. REGIMEN DD4A (weeks 1-6): Patients receive dactinomycin IV over 1-5 minutes once in week 1; vincristine IV once in weeks 1-6; and doxorubicin hydrochloride IV over 15 minutes once in week 4 in the absence of disease progression or unacceptable toxicity. Patients with both pulmonary and extra-pulmonary metastases at diagnosis undergo radiotherapy once daily beginning in week 1 and continuing for 5-14 days. After completion of DD4A chemotherapy (week 6), patients undergo evaluation. Patients with stage IV disease and pulmonary metastases only with no loss of heterozygosity (LOH) who are rapid complete responders (RCR) (i.e., all pulmonary metastases disappear) proceed to regimen DD4A (weeks 7-25). All other patients (i.e., patients with stage III or IV disease and LOH of both 1p and 16q; stage IV disease with pulmonary metastases only who are slow incomplete responders [SIR] [i.e., pulmonary metastases do not disappear]; or stage IV disease with nonpulmonary metastases or with nonpulmonary metastases in combination with pulmonary metastases proceed to regimen M (weeks 7-31).

Outcome Measures

Primary: Event Free Survival Probability [ Time Frame: 4 years ] Event Free Survival (EFS) Probability [ Time Frame: At 4 years ] Event Free Survival Probability [ Time Frame: At 4 years ] Secondary: Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease [ Time Frame: At 4 years ]

NCI Description

?NCT00379340-D2? is required for recreating the results of NWTS-5 as presented in the manuscript. Each row corresponds with the results for a single patient. The datasets also provide patient data necessary for recreating the experimental cohorts as well as characteristics of the initial disease, treatment, and outcomes.

Clinical Trial Title

Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

Trial Summary and Conditions

This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Favorable Histology Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. Determine the 4-year event-free survival (EFS) of patients with stage IV favorable histology (FH) Wilms' tumor with pulmonary metastases only who have complete resolution of pulmonary lesions without whole lung irradiation treated with DD4A chemotherapy comprising vincristine, dactinomycin, and doxorubicin hydrochloride. II. Determine the 4-year EFS of these patients who do not have resolution of pulmonary metastases by week 6 treated with the addition of cyclophosphamide and etoposide to a modified-regimen DD4A (regimen M). III. Determine the 4-year EFS of patients with stage III or IV FH Wilms' tumor with loss of heterozygosity for chromosomes 1p and 16q treated with regimen M. SECONDARY OBJECTIVES: I. Correlate the burden of pulmonary metastatic disease with outcome in patients with stage IV FH Wilms' tumor. OUTLINE: This is a multicenter study. REGIMEN DD4A (weeks 1-6): Patients receive dactinomycin IV over 1-5 minutes once in week 1; vincristine IV once in weeks 1-6; and doxorubicin hydrochloride IV over 15 minutes once in week 4 in the absence of disease progression or unacceptable toxicity. Patients with both pulmonary and extra-pulmonary metastases at diagnosis undergo radiotherapy once daily beginning in week 1 and continuing for 5-14 days. After completion of DD4A chemotherapy (week 6), patients undergo evaluation. Patients with stage IV disease and pulmonary metastases only with no loss of heterozygosity (LOH) who are rapid complete responders (RCR) (i.e., all pulmonary metastases disappear) proceed to regimen DD4A (weeks 7-25). All other patients (i.e., patients with stage III or IV disease and LOH of both 1p and 16q; stage IV disease with pulmonary metastases only who are slow incomplete responders [SIR] [i.e., pulmonary metastases do not disappear]; or stage IV disease with nonpulmonary metastases or with nonpulmonary metastases in combination with pulmonary metastases proceed to regimen M (weeks 7-31).

Outcome Measures

Primary: Event Free Survival Probability [ Time Frame: 4 years ] Event Free Survival (EFS) Probability [ Time Frame: At 4 years ] Event Free Survival Probability [ Time Frame: At 4 years ] Secondary: Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease [ Time Frame: At 4 years ]

NCI Description

NCT00379340-D3 These data provide specific incidences of adverse events. ?NCT00379340-D3? is necessary for recreating table A2, each row corresponds to a single Adverse Event.

Clinical Trial Title

Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

Trial Summary and Conditions

This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Favorable Histology Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. Determine the 4-year event-free survival (EFS) of patients with stage IV favorable histology (FH) Wilms' tumor with pulmonary metastases only who have complete resolution of pulmonary lesions without whole lung irradiation treated with DD4A chemotherapy comprising vincristine, dactinomycin, and doxorubicin hydrochloride. II. Determine the 4-year EFS of these patients who do not have resolution of pulmonary metastases by week 6 treated with the addition of cyclophosphamide and etoposide to a modified-regimen DD4A (regimen M). III. Determine the 4-year EFS of patients with stage III or IV FH Wilms' tumor with loss of heterozygosity for chromosomes 1p and 16q treated with regimen M. SECONDARY OBJECTIVES: I. Correlate the burden of pulmonary metastatic disease with outcome in patients with stage IV FH Wilms' tumor. OUTLINE: This is a multicenter study. REGIMEN DD4A (weeks 1-6): Patients receive dactinomycin IV over 1-5 minutes once in week 1; vincristine IV once in weeks 1-6; and doxorubicin hydrochloride IV over 15 minutes once in week 4 in the absence of disease progression or unacceptable toxicity. Patients with both pulmonary and extra-pulmonary metastases at diagnosis undergo radiotherapy once daily beginning in week 1 and continuing for 5-14 days. After completion of DD4A chemotherapy (week 6), patients undergo evaluation. Patients with stage IV disease and pulmonary metastases only with no loss of heterozygosity (LOH) who are rapid complete responders (RCR) (i.e., all pulmonary metastases disappear) proceed to regimen DD4A (weeks 7-25). All other patients (i.e., patients with stage III or IV disease and LOH of both 1p and 16q; stage IV disease with pulmonary metastases only who are slow incomplete responders [SIR] [i.e., pulmonary metastases do not disappear]; or stage IV disease with nonpulmonary metastases or with nonpulmonary metastases in combination with pulmonary metastases proceed to regimen M (weeks 7-31).

Outcome Measures

Primary: Event Free Survival Probability [ Time Frame: 4 years ] Event Free Survival (EFS) Probability [ Time Frame: At 4 years ] Event Free Survival Probability [ Time Frame: At 4 years ] Secondary: Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease [ Time Frame: At 4 years ]

NCI Description

NCT00379340-D4 These data provide specific incidences of adverse events. ?NCT00379340-D4? is necessary for recreating table A3 in the manuscript. Each row corresponds to a single Adverse Event.

Clinical Trial Title

Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

Trial Summary and Conditions

This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Favorable Histology Wilms' tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more tumor cells.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. Determine the 4-year event-free survival (EFS) of patients with stage IV favorable histology (FH) Wilms' tumor with pulmonary metastases only who have complete resolution of pulmonary lesions without whole lung irradiation treated with DD4A chemotherapy comprising vincristine, dactinomycin, and doxorubicin hydrochloride. II. Determine the 4-year EFS of these patients who do not have resolution of pulmonary metastases by week 6 treated with the addition of cyclophosphamide and etoposide to a modified-regimen DD4A (regimen M). III. Determine the 4-year EFS of patients with stage III or IV FH Wilms' tumor with loss of heterozygosity for chromosomes 1p and 16q treated with regimen M. SECONDARY OBJECTIVES: I. Correlate the burden of pulmonary metastatic disease with outcome in patients with stage IV FH Wilms' tumor. OUTLINE: This is a multicenter study. REGIMEN DD4A (weeks 1-6): Patients receive dactinomycin IV over 1-5 minutes once in week 1; vincristine IV once in weeks 1-6; and doxorubicin hydrochloride IV over 15 minutes once in week 4 in the absence of disease progression or unacceptable toxicity. Patients with both pulmonary and extra-pulmonary metastases at diagnosis undergo radiotherapy once daily beginning in week 1 and continuing for 5-14 days. After completion of DD4A chemotherapy (week 6), patients undergo evaluation. Patients with stage IV disease and pulmonary metastases only with no loss of heterozygosity (LOH) who are rapid complete responders (RCR) (i.e., all pulmonary metastases disappear) proceed to regimen DD4A (weeks 7-25). All other patients (i.e., patients with stage III or IV disease and LOH of both 1p and 16q; stage IV disease with pulmonary metastases only who are slow incomplete responders [SIR] [i.e., pulmonary metastases do not disappear]; or stage IV disease with nonpulmonary metastases or with nonpulmonary metastases in combination with pulmonary metastases proceed to regimen M (weeks 7-31).

Outcome Measures

Primary: Event Free Survival Probability [ Time Frame: 4 years ] Event Free Survival (EFS) Probability [ Time Frame: At 4 years ] Event Free Survival Probability [ Time Frame: At 4 years ] Secondary: Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease [ Time Frame: At 4 years ]

NCI Description

NCT00392327-D1-Dataset As of June 2019, there are two datasets associated with this publication (PMID 30332335). The first dataset (D1) contains patient characteristics, toxicity, methylation profiling results and primary outcome analyses for the subset of patients with institutionally diagnosed supratentorial primitive neuroectodermal tumors of the CNS (CNS-PNETs) and pineoblastomas (PBLs) who were enrolled on ACNS0332 as reported in the manuscript (n=85).

Clinical Trial Title

Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients

Trial Summary and Conditions

This randomized phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To determine whether carboplatin radiosensitization increases long term event-free survival for high risk medulloblastoma/primitive neuroectodermal tumor (PNET) patients. II. To determine whether isotretinoin increases long term event-free survival for high risk medulloblastoma/PNET patients. SECONDARY OBJECTIVES: I. To compare residual disease response to radiation alone versus radiation plus carboplatin. II. To identify molecular prognostic indicators suitable for patient stratification in future trials. III. To evaluate the health-related quality of life (HRQOL) during phases of active treatment specific to treatment modalities. IV. To describe the neuropsychological functioning of the study population and to evaluate the relationship between neuropsychological status and health related quality of life. OUTLINE: Patients are randomized to Arm A or Arm B (Arms C and D closed to accrual as of Amendment 3 1/27/15).

Outcome Measures

Primary: Event-free survival (EFS) percentage [ Time Frame: Time from disease progression or recurrence, occurrence of a second malignant neoplasm, or death from any cause, assessed up to 10 years ] Secondary: Tumor response to radiation therapy with or without carboplatin [ Time Frame: Up to 10 years ] Time to death [ Time Frame: Up to 10 years ]

NCI Description

NCT00392327-D2-Dataset The second dataset (D2) contains data provided by the central pathologist on the 10 patients who were selected for a second central pathology review, given the discrepancies between profiling and centrally reviewed histopathologic diagnoses. This second central pathology review was done at the request of one of the journal article reviewers. The text in the results section of the manuscript and the associated data are geared towards pathologists rather than the general readership.

Clinical Trial Title

Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients

Trial Summary and Conditions

This randomized phase III trial studies different chemotherapy and radiation therapy regimens to compare how well they work in treating young patients with newly diagnosed, previously untreated, high-risk medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cisplatin, cyclophosphamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating brain tumors.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To determine whether carboplatin radiosensitization increases long term event-free survival for high risk medulloblastoma/primitive neuroectodermal tumor (PNET) patients. II. To determine whether isotretinoin increases long term event-free survival for high risk medulloblastoma/PNET patients. SECONDARY OBJECTIVES: I. To compare residual disease response to radiation alone versus radiation plus carboplatin. II. To identify molecular prognostic indicators suitable for patient stratification in future trials. III. To evaluate the health-related quality of life (HRQOL) during phases of active treatment specific to treatment modalities. IV. To describe the neuropsychological functioning of the study population and to evaluate the relationship between neuropsychological status and health related quality of life. OUTLINE: Patients are randomized to Arm A or Arm B (Arms C and D closed to accrual as of Amendment 3 1/27/15).

Outcome Measures

Primary: Event-free survival (EFS) percentage [ Time Frame: Time from disease progression or recurrence, occurrence of a second malignant neoplasm, or death from any cause, assessed up to 10 years ] Secondary: Tumor response to radiation therapy with or without carboplatin [ Time Frame: Up to 10 years ] Time to death [ Time Frame: Up to 10 years ]

NCI Description

There is one dataset associated with this publication. This dataset is associated with the manuscript titled, ?Results of the first Prospective Multi-Institutional Treatment Study in Children with Bilateral Wilms Tumor (AREN0534): A report from the Children's Oncology Group.?

Clinical Trial Title

Treatment for Patients With Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor

Trial Summary and Conditions

This phase III trial studies how well combination chemotherapy and surgery work in treating young patients with Wilms tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: I. To improve 4-year event-free survival (EFS) to 73% for young patients with bilateral Wilms tumor (BWT). II. To prevent complete removal of at least one kidney in 50% of patients with BWT by using prenephrectomy 3-drug chemotherapy induction with vincristine (vincristine sulfate), dactinomycin, and doxorubicin (doxorubicin hydrochloride). III. To evaluate the efficacy of chemotherapy in preserving renal units in children with diffuse hyperplastic perilobar nephroblastomatosis (DHPLN) and preventing Wilms tumor development. IV. To facilitate partial nephrectomy in lieu of nephrectomy in 25% of children with unilateral tumors and aniridia, Beckwith-Wiedemann syndrome (BWS), hemihypertrophy or other overgrowth syndromes, by using prenephrectomy 2-drug chemotherapy induction with vincristine and dactinomycin. V. To have 75% of patients with BWT undergo definitive surgical treatment by 12 weeks after initiation of chemotherapy. OUTLINE: Patients are assigned to 1 of 3 arms. ARM 1 (Bilateral Wilms Tumors) ARM 2 (Unilateral High Risk tumors bilaterally predisposed) ARM 3 (DHPLN)

Outcome Measures

Primary: Event-Free Survival (EFS) [ Time Frame: 4 years from study enrollment ] Kidney Preservation After Preoperative Chemotherapy [ Time Frame: 12 weeks from study entry ] Number of Patients Without Complete Removal of at Least One Kidney [ Time Frame: 12 weeks from the study entry ] Percentage of Patients Who Experienced Partial Nephrectomy After Preoperative Chemotherapy [ Time Frame: 12 weeks from study entry ] Percentage of Patients Who Had Definitive Surgical Treatment [ Time Frame: 12 weeks from study entry ]

NCI Description

NCT00354744-D1 There is one row for each patient enrolled. The dataset contains the patient characteristics, Oberlin risk groups, reporting period duration, radiation by reporting period, and survival outcomes for patients on ARST0431 as reported in the manuscript.

Clinical Trial Title

Intensive Multi-Agent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide (IE) and Vincristine/Doxorubicin/Cyclophosphamide (VDC) for Patients With High-Risk Rhabdomyosarcoma

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy, such as vincristine, irinotecan, ifosfamide, etoposide, doxorubicin, cyclophosphamide, and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase III trial is studying how well giving high-dose combination chemotherapy together with radiation therapy works in treating patients with newly diagnosed metastatic rhabdomyosarcoma or ectomesenchymoma.

Data Summary

See data dictionary for more details.

Study Objectives

Primary: Improve the early disease control interval for patients with newly diagnosed, high-risk, metastatic rhabdomyosarcoma or ectomesenchymoma using intensive, interval-compression therapy (comprising vincristine, irinotecan hydrochloride, ifosfamide, etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin) that permits maximal early exposure to known effective agents. Determine the feasibility of concurrent irinotecan hydrochloride and radiotherapy in these patients. Assess immediate- and short-term side effects of concurrent irinotecan hydrochloride and radiotherapy in these patients. Secondary: Expand the available data for response to irinotecan hydrochloride and vincristine in previously untreated patients with high-risk rhabdomyosarcoma. Evaluate, prospectively, and validate gene expression values with the intent to define the best diagnostic predictors and more powerful prognostic classifiers. OUTLINE: This is a prospective, nonrandomized, multicenter study. Patients are stratified according to prognostic factors predictive of outcome (e.g. histology, bone/bone marrow involvement, and number of metastatic sites).

Outcome Measures

Primary: Tumor Response Rate [ Time Frame: Protocol week 6 evaluation ] Estimate of the Percent of Patients Event Free at 4 Years Following Study Entry [ Time Frame: 4 years ] Secondary: Early Disease Control [ Time Frame: 2 years ] Feasibility [ Time Frame: 2 years ] Toxicity [ Time Frame: 2 years ]

NCI Description

NCT00354744-D2 This dataset contains incidence of adverse events as reported in the manuscript.

Clinical Trial Title

Intensive Multi-Agent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide (IE) and Vincristine/Doxorubicin/Cyclophosphamide (VDC) for Patients With High-Risk Rhabdomyosarcoma

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy, such as vincristine, irinotecan, ifosfamide, etoposide, doxorubicin, cyclophosphamide, and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase III trial is studying how well giving high-dose combination chemotherapy together with radiation therapy works in treating patients with newly diagnosed metastatic rhabdomyosarcoma or ectomesenchymoma.

Data Summary

See data dictionary for more details.

Study Objectives

Primary: Improve the early disease control interval for patients with newly diagnosed, high-risk, metastatic rhabdomyosarcoma or ectomesenchymoma using intensive, interval-compression therapy (comprising vincristine, irinotecan hydrochloride, ifosfamide, etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin) that permits maximal early exposure to known effective agents. Determine the feasibility of concurrent irinotecan hydrochloride and radiotherapy in these patients. Assess immediate- and short-term side effects of concurrent irinotecan hydrochloride and radiotherapy in these patients. Secondary: Expand the available data for response to irinotecan hydrochloride and vincristine in previously untreated patients with high-risk rhabdomyosarcoma. Evaluate, prospectively, and validate gene expression values with the intent to define the best diagnostic predictors and more powerful prognostic classifiers. OUTLINE: This is a prospective, nonrandomized, multicenter study. Patients are stratified according to prognostic factors predictive of outcome (e.g. histology, bone/bone marrow involvement, and number of metastatic sites).

Outcome Measures

Primary: Tumor Response Rate [ Time Frame: Protocol week 6 evaluation ] Estimate of the Percent of Patients Event Free at 4 Years Following Study Entry [ Time Frame: 4 years ] Secondary: Early Disease Control [ Time Frame: 2 years ] Feasibility [ Time Frame: 2 years ] Toxicity [ Time Frame: 2 years ]

NCI Description

This dataset contains the analysis data for the MetaSite BreastTM score analysis (n=600) published in PMID 29138761 with a subset of cases from the parent trial NCT00003519.

Clinical Trial Title

Phase III Study of Adriamycin/Taxotere Versus Adriamycin/Cytoxan for the Adjuvant Treatment of Node Positive or High Risk Node Negative Breast Cancer

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating women with breast cancer who have undergone surgery to remove the tumor.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: I. Determine whether doxorubicin/docetaxel (DD) will improve disease-free survival and overall survival when compared to doxorubicin/cyclophosphamide (DC) in women with lymph node positive (1-3 positive nodes) or high risk lymph node negative breast cancer. II. Compare the toxicity of DD to DC in this patient population. OUTLINE: This is a randomized study. Patients are stratified by node status (positive vs negative), menopause status (pre- vs post), estrogen receptor (ER) status/progesterone receptor (PR) status (ER/PR unknown vs ER+/PR+ vs ER+/PR- vs ER-/PR+ vs ER-/PR-). Patients in arm I receive doxorubicin IV plus docetaxel IV over 1 hour every 3 weeks for 4 treatment courses. Patients in arm II receive doxorubicin IV plus cyclophosphamide IV every 3 weeks for 4 treatment courses. All patients who are estrogen receptor or progesterone receptor positive receive oral tamoxifen daily for 5 years following chemotherapy. Some patients may also receive radiotherapy following chemotherapy. Patients are followed every 3 months if patient is less than 2 years from study entry; every 6 months if patient is 2-5 years from study entry; and every 12 months if patient is greater than 5 years from study entry. PROJECTED ACCRUAL: Approximately 2778 patients will be accrued for this study within 2.5 years.

Outcome Measures

N/A

NCI Description

This dataset contains the analysis data published in PMID 29860917 from trial TAILORx (NCT00310180).

Clinical Trial Title

Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment:The TAILORx Trial

Trial Summary and Conditions

This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To determine whether adjuvant hormonal therapy is not inferior to adjuvant chemohormonal in women whose tumors meet established clinical guidelines for adjuvant chemotherapy and fall in the "primary study group" category (Oncotype DX Recurrence Score 11-25). II. To create a tissue and specimen bank for patients enrolled in this trial, including formalin fixed paraffin embedded tumor specimens, tissue microarrays, plasma, and deoxyribonucleic acid (DNA) obtained from peripheral blood. SECONDARY OBJECTIVES: I. To determine whether adjuvant hormonal therapy is sufficient treatment (i.e. 10 year distant disease-free survival of at least 95%) for women whose tumors meet established clinical guidelines for adjuvant chemotherapy and who fall into the "Secondary Study Group-1" category (Oncotype DX Recurrence Score less than 10). II. To compare the outcomes projected at 10 years by Adjuvant (with outcomes projected using classical pathologic information including tumor size, hormone receptor status, and histologic grade) with those made by the Genomic Health Oncotype DX test. Classical pathologic information and outcome results will also be used to create and refine models that would use classical information instead of or in combination with genomic tests. III. To estimate failure rates as a function of recurrence score (RS) separately in the chemotherapy (arms C, D) and no chemotherapy (arms A, B) groups. The purpose of the analysis is to develop more precise estimates of the relationship between recurrence score and chemotherapy treatment effect, if any, at the upper range of the RS 11 - 25 group. IV. To determine the prognostic significance of the Oncotype DX recurrence score and of the individual RS gene groups (proliferation gene group, human epidermal growth factor receptor [HER]2 gene group, estrogen receptor [ER] gene group, invasion gene group, and other genes).

Outcome Measures

Primary: 5-year Disease-free Survival [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years ] Secondary: 5-year Distant Recurrence-free Interval [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DRFI rate estimated at 5 years ] 5-year Recurrence-free Interval [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, RFS rate estimated at 5 years ] 5-year Overall Survival [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, OS rate estimated at 5 years ] 5-year Disease-free Survival by Age and Recurrence Score Groups [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years, DFS rate estimated at 5 years ] To Compare the Outcomes Projected at 10 Years by Adjuvant! With Those Made by the Genomic Health Oncotype DX Test [ Time Frame: Assessed at 10 years after study entry ] 5-year Disease-free Survival by Individual RS Gene Groups [ Time Frame: Assessed every 6 months within 5 years from registration and then annually up to 20 years ]

NCI Description

There are four different submissions (each with one dataset) for PMID 29129443 (trial NCT00324805). This dataset, NCT00324805-D1, contains baseline, treatment, and efficacy data. Dataset NCT00324805-D2 contains toxicity data for duplicating the results in Table 2 of the manuscript. Dataset NCT00324805-D3 contains toxicity data for duplicating the results in Table 3 of the manuscript. Dataset NCT00324805-D4 can be used to derive the number of patients with worst degree 1/2 toxicities (bottom row of Table 2); and the worst degree grade 3-5 events in Table 3 and Supplement.

Clinical Trial Title

A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (greater than or equal to 4 cm) - IIIA Non-small Cell Lung Cancer (NSCLC)

Trial Summary and Conditions

This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To evaluate overall survival with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>= 4 cm) - IIIA non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To evaluate disease-free survival and toxicity with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>= 4 cm) - IIIA NSCLC. CORRELATIVE OBJECTIVES: I. To perform analyses of tissue and blood to establish factors that predict clinical outcome in patients receiving chemotherapy, with or without bevacizumab, for resected early stage NSCLC. II. To determine whether smoking status is linked to outcome for patients with resected stage IB (>= 4 cm) - IIIA NSCLC treated with chemotherapy with or without bevacizumab in the adjuvant setting. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I (adjuvant chemotherapy without bevacizumab): Patients receive 1 of 4 chemotherapy regimens. REGIMEN 1: Patients receive vinorelbine ditartrate intravenously (IV) over 10 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following vinorelbine ditartrate administration. REGIMEN 2: Patients receive docetaxel IV over 1 hour on day 1 and cisplatin over 1 hour on day 1 immediately following docetaxel administration. REGIMEN 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following gemcitabine administration. REGIMEN 4 (non-squamous histology only): Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1 hour on day 1 immediately following pemetrexed disodium administration. ARM II (adjuvant chemotherapy with bevacizumab): Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

Outcome Measures

Primary: Overall Survival [ Time Frame: From registration to death, up to 10 years ] Secondary: Disease-free Survival [ Time Frame: From registration to death, up to 10 years ]

NCI Description

There are four different submissions (each with one dataset) for PMID 29129443 (trial NCT00324805). This dataset, NCT00324805-D2, contains toxicity data for duplicating the results in Table 2 of the manuscript. Dataset NCT00324805-D1 contains baseline, treatment, and efficacy data. Dataset NCT00324805-D3 contains toxicity data for duplicating the results in Table 3 of the manuscript. Dataset NCT00324805-D4 can be used to derive the number of patients with worst degree 1/2 toxicities (bottom row of Table 2); and the worst degree grade 3-5 events in Table 3 and Supplement.

Clinical Trial Title

A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (greater than or equal to 4 cm) - IIIA Non-small Cell Lung Cancer (NSCLC)

Trial Summary and Conditions

This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To evaluate overall survival with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>= 4 cm) - IIIA non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To evaluate disease-free survival and toxicity with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>= 4 cm) - IIIA NSCLC. CORRELATIVE OBJECTIVES: I. To perform analyses of tissue and blood to establish factors that predict clinical outcome in patients receiving chemotherapy, with or without bevacizumab, for resected early stage NSCLC. II. To determine whether smoking status is linked to outcome for patients with resected stage IB (>= 4 cm) - IIIA NSCLC treated with chemotherapy with or without bevacizumab in the adjuvant setting. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I (adjuvant chemotherapy without bevacizumab): Patients receive 1 of 4 chemotherapy regimens. REGIMEN 1: Patients receive vinorelbine ditartrate intravenously (IV) over 10 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following vinorelbine ditartrate administration. REGIMEN 2: Patients receive docetaxel IV over 1 hour on day 1 and cisplatin over 1 hour on day 1 immediately following docetaxel administration. REGIMEN 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following gemcitabine administration. REGIMEN 4 (non-squamous histology only): Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1 hour on day 1 immediately following pemetrexed disodium administration. ARM II (adjuvant chemotherapy with bevacizumab): Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

Outcome Measures

Primary: Overall Survival [ Time Frame: From registration to death, up to 10 years ] Secondary: Disease-free Survival [ Time Frame: From registration to death, up to 10 years ]

NCI Description

There are four different submissions (each with one dataset) for PMID 29129443 (trial NCT00324805). This dataset, NCT00324805-D3, contains toxicity data for duplicating the results in Table 3 of the manuscript. Dataset NCT00324805-D1 contains baseline, treatment, and efficacy data. Dataset NCT00324805-D2 contains toxicity data for duplicating the results in Table 2 of the manuscript. Dataset NCT00324805-D4 can be used to derive the number of patients with worst degree 1/2 toxicities (bottom row of Table 2); and the worst degree grade 3-5 events in Table 3 and Supplement.

Clinical Trial Title

A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (greater than or equal to 4 cm) - IIIA Non-small Cell Lung Cancer (NSCLC)

Trial Summary and Conditions

This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To evaluate overall survival with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>= 4 cm) - IIIA non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To evaluate disease-free survival and toxicity with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>= 4 cm) - IIIA NSCLC. CORRELATIVE OBJECTIVES: I. To perform analyses of tissue and blood to establish factors that predict clinical outcome in patients receiving chemotherapy, with or without bevacizumab, for resected early stage NSCLC. II. To determine whether smoking status is linked to outcome for patients with resected stage IB (>= 4 cm) - IIIA NSCLC treated with chemotherapy with or without bevacizumab in the adjuvant setting. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I (adjuvant chemotherapy without bevacizumab): Patients receive 1 of 4 chemotherapy regimens. REGIMEN 1: Patients receive vinorelbine ditartrate intravenously (IV) over 10 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following vinorelbine ditartrate administration. REGIMEN 2: Patients receive docetaxel IV over 1 hour on day 1 and cisplatin over 1 hour on day 1 immediately following docetaxel administration. REGIMEN 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following gemcitabine administration. REGIMEN 4 (non-squamous histology only): Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1 hour on day 1 immediately following pemetrexed disodium administration. ARM II (adjuvant chemotherapy with bevacizumab): Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

Outcome Measures

Primary: Overall Survival [ Time Frame: From registration to death, up to 10 years ] Secondary: Disease-free Survival [ Time Frame: From registration to death, up to 10 years ]

NCI Description

There are four different submissions (each with one dataset) for PMID 29129443 (trial NCT00324805). This dataset, NCT00324805-D4, can be used to derive the number of patients with worst degree 1/2 toxicities (bottom row of Table 2); and the worst degree grade 3-5 events in Table 3 and Supplement. Dataset NCT00324805-D1 contains baseline, treatment, and efficacy data. Dataset NCT00324805-D2 contains toxicity data for duplicating the results in Table 2 of the manuscript. Dataset NCT00324805-D3 contains toxicity data for duplicating the results in Table 3 of the manuscript.

Clinical Trial Title

A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (greater than or equal to 4 cm) - IIIA Non-small Cell Lung Cancer (NSCLC)

Trial Summary and Conditions

This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To evaluate overall survival with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>= 4 cm) - IIIA non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To evaluate disease-free survival and toxicity with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>= 4 cm) - IIIA NSCLC. CORRELATIVE OBJECTIVES: I. To perform analyses of tissue and blood to establish factors that predict clinical outcome in patients receiving chemotherapy, with or without bevacizumab, for resected early stage NSCLC. II. To determine whether smoking status is linked to outcome for patients with resected stage IB (>= 4 cm) - IIIA NSCLC treated with chemotherapy with or without bevacizumab in the adjuvant setting. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I (adjuvant chemotherapy without bevacizumab): Patients receive 1 of 4 chemotherapy regimens. REGIMEN 1: Patients receive vinorelbine ditartrate intravenously (IV) over 10 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following vinorelbine ditartrate administration. REGIMEN 2: Patients receive docetaxel IV over 1 hour on day 1 and cisplatin over 1 hour on day 1 immediately following docetaxel administration. REGIMEN 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following gemcitabine administration. REGIMEN 4 (non-squamous histology only): Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1 hour on day 1 immediately following pemetrexed disodium administration. ARM II (adjuvant chemotherapy with bevacizumab): Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year.

Outcome Measures

Primary: Overall Survival [ Time Frame: From registration to death, up to 10 years ] Secondary: Disease-free Survival [ Time Frame: From registration to death, up to 10 years ]

NCI Description

This dataset contains all the data used in the publication cited above (PMID=26287032). Baseline demographic and clinical variables are provided for time = 0 (baseline visit). The primary outcome measures for the study are assessed at each time (0=baseline, 4=4 weeks, 8=8 weeks, and 12=12 weeks). Summary measures that are calculated across the participant?s time on study (e.g., worst toxicities and compliance) are recorded on the time = 99 rows. Note that these are measures determined over the entire study period, not a specific time. Notes: Missing data are denoted by a blank or a ?.? for each variable.

Clinical Trial Title

A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors

Trial Summary and Conditions

RATIONALE: L-arginine supplements may improve the quality of life and sexual function in women who are cancer survivors. PURPOSE: This randomized clinical trial is studying an L-arginine supplement to see how well it works compared with a placebo in treating women who are cancer survivors.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Primary: Determine whether an L-arginine-based nutritional supplement (ArginMax?) improves the quality of life and sexual function in female cancer survivors. Secondary: Compare quality of life of patients treated with ArginMax? vs placebo. Compare toxicity of these regimens in these patients. Describe the sexual function symptom clusters (if any) in these patients. OUTLINE: This is a randomized, double-blind, parallel-group, placebo-controlled, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2 or 3), type of malignancy (pelvic vs nonpelvic), and ovarian functional status (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive an oral L-arginine-based nutritional supplement (ArginMax?) twice daily. Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 12 weeks in the absence of unacceptable toxicity. Sexual function, quality of life, and toxicity are assessed at baseline and every 4 weeks for 12 weeks. PROJECTED ACCRUAL: A total of 186 patients will be accrued for this study.

Outcome Measures

Primary: Sexual Function [ Time Frame: 12 weeks ] Secondary: Quality of Life [ Time Frame: 12 weeks ]

NCI Description

This dataset will allow users to reproduce the treatment comparison between arm 1 and arm 2 in trial NCT03722355.

Clinical Trial Title

A Phase III Comparison of Hyperfractionated Radiation Therapy (RT) With BCNU and Conventional RT With BCNU for Supratentorial Malignant Glioma

Trial Summary and Conditions

Hyperfractionated radiation therapy (RT) to 72.0 Gy with BCNU will be compared to conventional radiation therapy to 60.0 Gy with BCNU to determine if hyperfractionated RT can improve the median survival time of adults with supratentorial malignant gliomas.

Data Summary

See data dictionary for more details.

Study Objectives

N/A

Outcome Measures

Primary: Overall Survival [ Time Frame: From randomization to the date of death or last follow up, assessed up to 131 months. ]

NCI Description

This dataset will allow users to reproduce the treatment comparison between arms in trial NCT00033631.

Clinical Trial Title

A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate Cancer

Trial Summary and Conditions

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating stage II prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different doses of specialized radiation therapy in treating patients who have stage II prostate cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Compare the overall survival of patients with stage II adenocarcinoma of the prostate treated with high- vs standard-dose three-dimensional conformal or intensity-modulated radiotherapy. Compare the freedom from prostate-specific antigen failure, disease-specific survival, local progression, and distant metastases in patients treated with these regimens. Compare the probability of tumor control and normal tissue complications in patients treated with these regimens. Compare the incidence of grade 2 or greater genitourinary and gastrointestinal acute and late toxicity in patients treated with these regimens. Compare the quality of life, including sexual function, of patients treated with these regimens. Correlate histopathologic or tumor-specific cytogenetic or chromosomal markers with cancer control outcomes in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score and prostate-specific antigen (PSA) level (Gleason score 2-6, PSA greater than or equal to 10 mg/mL but less than 20 ng/mL vs Gleason score 7, PSA less than 15 ng/mL) and radiation modality (three-dimensional conformal radiotherapy [3D-CRT] vs intensity-modulated radiotherapy [IMRT]). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo standard-dose 3D-CRT or IMRT once daily, 5 days a week, for 7.8 weeks (39 treatment days). Arm II: Patients undergo high-dose 3D-CRT or IMRT once daily, 5 days a week, for 8.8 weeks (44 treatment days). Quality of life (QOL) is assessed initially at baseline. After completion of radiotherapy, QOL is assessed every 3 months for 1 year and then every 6 months for 4 years. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,520 patients (760 per treatment arm) will be accrued for this study within 5 years.

Outcome Measures

Primary: Overall Survival [ Time Frame: From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years. ] Secondary: Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition [ Time Frame: From randomization to date of failure (3 consecutive rises) or death or last follow-up. ] Disease Specific Survival [ Time Frame: From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. ] Local Progression [ Time Frame: From randomization to date of failure (local progression) or death or last follow-up. ] Distant Metastases [ Time Frame: From randomization to date of failure (distant metastasis) or death or last follow-up. ] Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity [ Time Frame: From the start of treatment to 90 days. ] Erectile Function by International Index of Erectile Function (IIEF) [ Time Frame: From randomization to 5 years. ] Global Quality of Life (QOL) by Spitzer QOL Index (SQLI) [ Time Frame: From randomization to 5 years. ] Quality Adjusted Survival by SQLI [ Time Frame: From randomization to 5 years. ] Tumor Control Probability [ Time Frame: From randomization to date of failure (tumor progression) or last follow-up. ] Normal Tissue Complication Probability [ Time Frame: From randomization to last follow-up. ]

NCI Description

Dataset NCT00693992-D3-Dataset.csv (qol) is one of 3 datasets associated with PubMed ID 28161554. This dataset contains information that will allow you to reproduce the quality of life (qol) analysis. Due to data cleaning efforts, values may contain slight discrepancies from that reported in Table 1 of the Supplemental Materials.

Clinical Trial Title

Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511) as Maintenance Therapy in Non-progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB / IV Non-small Cell Lung Cancer

Trial Summary and Conditions

This randomized phase III trial studies sunitinib malate to see how well it works when given as maintenance therapy (meaning it is approved for treatment after chemotherapy) in patients with stage IIIB-IV non-small cell lung cancer who have responded to prior treatment with combination chemotherapy. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sunitinib malate is effective in helping tumors continue to shrink or stop growing.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To evaluate the effect of sunitinib (sunitinib malate) compared to placebo on progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients who have had either stable or responding disease over the course of their initial 4 cycles of platinum-based therapy. SECONDARY OBJECTIVES: I. To evaluate the toxicity of sunitinib compared to placebo in the maintenance setting. II. To evaluate the additional response rate as a result of sunitinib in this setting. III. To assess the impact of sunitinib on overall survival compared to the placebo arm. IV. To assess the impact of sunitinib on delaying the time to deterioration in quality of life and symptom progression compared to placebo using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and Lung Cancer Module (LC13). V. To assess vascular endothelial growth factor (VEGF) haplotypes in advanced non-small cell lung cancer and sunitinib maintenance. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 1 year, and then periodically for 3 years.

Outcome Measures

Primary: Progression Free Survival (PFS) [ Time Frame: Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years) ] Secondary: Overall Survival (OS) [ Time Frame: Time from randomization to death (up to 5 years) ] Response Rate (RR) [ Time Frame: Duration of treatment (up to 5 years) ] Percentage of Deterioration in QOL at 3 Months Using the EORTC QLQ-C30 Global Health Subscale [ Time Frame: At 3 months ] Percentage of Deterioration in Symptom Progression at 3 Months Using the EORTC LC13 Dyspnea Subscale [ Time Frame: At 3 months ] Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: Duration of study (up to 5 years) ]

NCI Description

Dataset NCT00693992-D2-Dataset.csv (toxicity) is one of 3 datasets associated with PubMed ID 28161554. This dataset contains information that will allow you to reproduce the toxicity analysis.

Clinical Trial Title

Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511) as Maintenance Therapy in Non-progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB / IV Non-small Cell Lung Cancer

Trial Summary and Conditions

This randomized phase III trial studies sunitinib malate to see how well it works when given as maintenance therapy (meaning it is approved for treatment after chemotherapy) in patients with stage IIIB-IV non-small cell lung cancer who have responded to prior treatment with combination chemotherapy. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sunitinib malate is effective in helping tumors continue to shrink or stop growing.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To evaluate the effect of sunitinib (sunitinib malate) compared to placebo on progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients who have had either stable or responding disease over the course of their initial 4 cycles of platinum-based therapy. SECONDARY OBJECTIVES: I. To evaluate the toxicity of sunitinib compared to placebo in the maintenance setting. II. To evaluate the additional response rate as a result of sunitinib in this setting. III. To assess the impact of sunitinib on overall survival compared to the placebo arm. IV. To assess the impact of sunitinib on delaying the time to deterioration in quality of life and symptom progression compared to placebo using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and Lung Cancer Module (LC13). V. To assess vascular endothelial growth factor (VEGF) haplotypes in advanced non-small cell lung cancer and sunitinib maintenance. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 1 year, and then periodically for 3 years.

Outcome Measures

Primary: Progression Free Survival (PFS) [ Time Frame: Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years) ] Secondary: Overall Survival (OS) [ Time Frame: Time from randomization to death (up to 5 years) ] Response Rate (RR) [ Time Frame: Duration of treatment (up to 5 years) ] Percentage of Deterioration in QOL at 3 Months Using the EORTC QLQ-C30 Global Health Subscale [ Time Frame: At 3 months ] Percentage of Deterioration in Symptom Progression at 3 Months Using the EORTC LC13 Dyspnea Subscale [ Time Frame: At 3 months ] Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: Duration of study (up to 5 years) ]

NCI Description

Dataset NCT00693992-D1-Dataset.csv (clinical) is one of 3 datasets associated with PubMed ID 28161554. This dataset contains information that will allow you to reproduce the baseline characteristics table and primary analysis.

Clinical Trial Title

Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511) as Maintenance Therapy in Non-progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB / IV Non-small Cell Lung Cancer

Trial Summary and Conditions

This randomized phase III trial studies sunitinib malate to see how well it works when given as maintenance therapy (meaning it is approved for treatment after chemotherapy) in patients with stage IIIB-IV non-small cell lung cancer who have responded to prior treatment with combination chemotherapy. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sunitinib malate is effective in helping tumors continue to shrink or stop growing.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To evaluate the effect of sunitinib (sunitinib malate) compared to placebo on progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients who have had either stable or responding disease over the course of their initial 4 cycles of platinum-based therapy. SECONDARY OBJECTIVES: I. To evaluate the toxicity of sunitinib compared to placebo in the maintenance setting. II. To evaluate the additional response rate as a result of sunitinib in this setting. III. To assess the impact of sunitinib on overall survival compared to the placebo arm. IV. To assess the impact of sunitinib on delaying the time to deterioration in quality of life and symptom progression compared to placebo using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and Lung Cancer Module (LC13). V. To assess vascular endothelial growth factor (VEGF) haplotypes in advanced non-small cell lung cancer and sunitinib maintenance. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 1 year, and then periodically for 3 years.

Outcome Measures

Primary: Progression Free Survival (PFS) [ Time Frame: Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years) ] Secondary: Overall Survival (OS) [ Time Frame: Time from randomization to death (up to 5 years) ] Response Rate (RR) [ Time Frame: Duration of treatment (up to 5 years) ] Percentage of Deterioration in QOL at 3 Months Using the EORTC QLQ-C30 Global Health Subscale [ Time Frame: At 3 months ] Percentage of Deterioration in Symptom Progression at 3 Months Using the EORTC LC13 Dyspnea Subscale [ Time Frame: At 3 months ] Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: Duration of study (up to 5 years) ]

NCI Description

NCT00369317-D1 is the only dataset associated with this publication. The dataset contains the CONSORT flow of patient enrollment, baseline characteristics, adverse events, MRD, cytogenetics, and primary outcome analyses for patients on AAML0431 as reported in the manuscript. Also, data for patients on A2971 are provided in order to compare brief baseline characteristics and outcome to patients on AAML0431.

Clinical Trial Title

The Treatment of Down Syndrome Children With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) Under the Age of 4 Years

Trial Summary and Conditions

This phase III trial is studying how well combination chemotherapy works in treating young patients with Down syndrome and acute myeloid leukemia or myelodysplastic syndromes. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. Determine the event-free survival (EFS) and overall survival rates in pediatric patients with Down syndrome (DS) and acute myeloid leukemia AML or myelodysplastic syndromes MDS treated with induction therapy comprising cytarabine, daunorubicin hydrochloride, thioguanine, and asparaginase followed by intensification therapy comprising cytarabine and etoposide. II. Determine if the EFS rate in these patients can be increased with an intensified course of cytarabine therapy during induction therapy, compared to the EFS rate of patients in protocol COG-A2971. III. Determine if the number of intrathecal chemotherapy treatments can be reduced in these patients. IV. Determine if the total cumulative anthracycline dose can be reduced in these patients. SECONDARY OBJECTIVES: I. Determine the type and degree of treatment-related toxicity in these patients. II. Determine the prevalence of leukemia phenotype and globin transcription factor 1 (GATA1) mutations of DS patients < 4 years of age at diagnosis. III. Determine the relationship of GATA1 mutations with leukemia phenotype and EFS rates of DS patients < 4 years of age at diagnosis. IV. Determine the relationship of minimal residual disease monitored by flow cytometry and remission status during and after completion of therapy based on bone marrow morphology. V. Examine parameters of in vitro drug sensitivity and in vivo Ara-C pharmacokinetics. VI. Examine gene expression profiles by microarrays and the relationship to leukemia phenotype and outcome. VII. Examine the relationship of functional polymorphisms in phase I and phase II detoxification genes and DNA repair pathways that may modify susceptibility to leukemia and outcome of therapy in DS children. VIII. Assess the effect of karyotypic abnormalities on survival. IX. Establish a DS leukemia cell bank for future biological studies.

Outcome Measures

Primary: Event-free Survival (EFS) at 3 Years [ Time from study entry to induction failure, relapse, or death assessed at 3 years. ] Overall Survival (OS) at 3 Years [ Time from study entry to death, assessed at 3 years. ] Secondary: Induction Remission Rate [ End of induction therapy (day 112) ] Percentage of Patients Experiencing Grade 3 or 4 Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [ From the beginning of induction therapy to the end of intensification therapy ] Prevalence of Leukemia Phenotype of DS Patients < 4 Years of Age at Diagnosis by Flow Cytometry [ At the start of therapy ] Prevalence of of GATA1 Mutations of DS Patients < 4 Years of Age at Diagnosis [ At baseline and at the end of therapy (intensification) or disease relapse ] Proportions of Patients in Morphologic Remission With Positive MRD by Flow Cytometry [ After Induction I therapy (day 28 from start of therapy) ] Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program [ Days 1, 2, 8, and 9 of induction II ] Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program [ Days 1, 2, 8, and 9 of induction II ] Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program [ Days 1, 2, 8, and 9 of induction II ] Gene Expression Profiles by Microarrays [ At baseline and at the time of relapse (if available) ]

NCI Description

This dataset will allow users to reproduce the treatment comparison between letrozole group and the placebo group in trial NCT00754845.

Clinical Trial Title

A Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed With Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen (Including Those in The MA.17 Study)

Trial Summary and Conditions

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating in women with breast cancer who have already received 5 years of aromatase inhibitor therapy. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating women with primary breast cancer who have received 5 years of aromatase inhibitor therapy.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Primary To compare the disease-free survival of women with primary breast cancer treated with letrozole vs placebo after completing approximately 5 years (i.e., 4? - 6 years) of aromatase inhibitor therapy (e.g., letrozole, anastrozole, or exemestane). Secondary To compare the effect of these drugs on overall (all cause specific) mortality of these patients. To compare the incidence of contralateral breast cancer in patients treated with these drugs. To evaluate the long-term clinical and laboratory safety of aromatase inhibitor therapy, particularly cardiovascular morbidity and mortality (e.g., significant coronary artery disease, including myocardial infarction and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft, fatal and nonfatal strokes, and all vascular deaths); incidence of all bone fractures (with particular emphasis on hip and wrist fractures as indicators of osteoporosis); changes in bone density; and common toxicities. To compare overall quality of life (QOL) and menopausal-specific QOL of patients treated with these drugs. OUTLINE: This is a multicenter study. Patients are stratified according to lymph node status at diagnosis (negative vs positive vs unknown), prior adjuvant chemotherapy (yes vs no), interval between last dose of aromatase inhibitor therapy and study randomization (< 6 months vs 6 months to 2 years), and duration of prior tamoxifen citrate use (0 vs < 2 years vs 2 - 4? years vs > 4? years). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral letrozole once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy. Arm II: Patients receive oral placebo once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.

Outcome Measures

Primary: Disease-free Survival (DFS) [ Time Frame: Unitil the end of study with a median follow up of 75 months ] Secondary: Incidence of Contralateral Breast Cancer [ Time Frame: 10 years ] Overall Survival (OS) [ Time Frame: Until the end of study with a median follow-up of 75 months ] Change From Baseline in Role Function- Physical Scale on SF(Short Form)-36 Health Survey [ Time Frame: 8 years ]

NCI Description

This dataset will allow users to reproduce the treatment comparison between letrozole group and the placebo group in trial NCT00003140 and NCT00754845.

Clinical Trial Title

Treatment comparison between letrozole group and the placebo group in trial NCT00003140 and NCT00754845.

Trial Summary and Conditions

N/A

Data Summary

See data dictionary for more details.

Study Objectives

N/A

Outcome Measures

N/A

NCI Description

There are two different submissions (each with one dataset) for trial NCT01989572. This dataset, NCT01989572-D2, contains toxicity data. The other dataset, NCT01989572-D1, contains baseline and efficacy data.

Clinical Trial Title

A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With "No Evidence of Disease" After Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma

Trial Summary and Conditions

This randomized phase III trial studies sargramostim (Granulocyte-macrophage colony-stimulating factor, GM-CSF) or vaccine therapy alone to see how well they work compared to sargramostim and vaccine therapy together in preventing disease recurrence in patients with locally advanced or stage IV melanoma that has been removed by surgery. Sargramostim may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether yeast derived sargramostim and vaccine therapy are more effective alone or together in preventing recurrence of melanoma.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To compare overall survival and recurrence-free survival of patients with completely resected stage IV melanoma or stage III melanoma with gross extranodal extension, satellites, and/or intransit lesions, treated with granulocyte macrophage colony-stimulating factor (GM-CSF) (sargramostim) vs. no GM-CSF, or other high risk patients listed in the eligibility section. SECONDARY OBJECTIVES: I. To compare, using a 2 x 2 factorial design, overall survival and recurrence-free survival of human leukocyte antigen (HLA)-A2 positive patients treated with peptide vaccination vs. no peptide vaccination. II. The following descriptive evaluations of survival and recurrence-free survival are planned for the HLA-A2 positive patients: (1) GM-CSF plus peptide vaccination vs. peptide vaccination alone; (2) GM-CSF plus peptide vaccination vs. GM-CSF alone; (3) GM-CSF plus peptide vaccination vs. placebo. III. Survival and recurrence-free survival of HLA-A2 positive patients not receiving peptide vaccination will be compared to that of HLA-A2 negative patients not receiving peptide vaccination. IV. To determine the influence of GM-CSF on circulating dendritic cell numbers and subpopulations in peripheral blood of patients receiving and not receiving GM-CSF. V. To determine, in HLA-A2 positive patients, whether immunization with peptides with or without GM-CSF elicits a measurable T-cell response as assessed by enzyme-linked immunosorbent spot (ELISPOT) and the major histocompatibility complex (MHC) tetramer assay, and to determine the functionality of these cells by intracellular cytokine staining.

Outcome Measures

Primary: Overall Survival [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15 ] Recurrence Free Survival [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15 ] Secondary: Overall Survival in Human Leukocyte Antigens-A2 (HLA-A2) Positive Patients [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years,up to year 15 ] Recurrence Free Survival in HLA-A2 Positive Patients [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15 ] 5-year Overall Survival Rate [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15 ] 5-year Recurrence Free Survival Rate [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15 ]

NCI Description

There are two different submissions (each with one dataset) for trial NCT01989572. This dataset, NCT01989572-D1, contains baseline and efficacy data. The second dataset, NCT01989572-D2, contains toxicity data.

Clinical Trial Title

A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination Versus Placebo in Patients With "No Evidence of Disease" After Complete Surgical Resection of "Locally Advanced" and/or Stage IV Melanoma

Trial Summary and Conditions

This randomized phase III trial studies sargramostim (Granulocyte-macrophage colony-stimulating factor, GM-CSF) or vaccine therapy alone to see how well they work compared to sargramostim and vaccine therapy together in preventing disease recurrence in patients with locally advanced or stage IV melanoma that has been removed by surgery. Sargramostim may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether yeast derived sargramostim and vaccine therapy are more effective alone or together in preventing recurrence of melanoma.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To compare overall survival and recurrence-free survival of patients with completely resected stage IV melanoma or stage III melanoma with gross extranodal extension, satellites, and/or intransit lesions, treated with granulocyte macrophage colony-stimulating factor (GM-CSF) (sargramostim) vs. no GM-CSF, or other high risk patients listed in the eligibility section. SECONDARY OBJECTIVES: I. To compare, using a 2 x 2 factorial design, overall survival and recurrence-free survival of human leukocyte antigen (HLA)-A2 positive patients treated with peptide vaccination vs. no peptide vaccination. II. The following descriptive evaluations of survival and recurrence-free survival are planned for the HLA-A2 positive patients: (1) GM-CSF plus peptide vaccination vs. peptide vaccination alone; (2) GM-CSF plus peptide vaccination vs. GM-CSF alone; (3) GM-CSF plus peptide vaccination vs. placebo. III. Survival and recurrence-free survival of HLA-A2 positive patients not receiving peptide vaccination will be compared to that of HLA-A2 negative patients not receiving peptide vaccination. IV. To determine the influence of GM-CSF on circulating dendritic cell numbers and subpopulations in peripheral blood of patients receiving and not receiving GM-CSF. V. To determine, in HLA-A2 positive patients, whether immunization with peptides with or without GM-CSF elicits a measurable T-cell response as assessed by enzyme-linked immunosorbent spot (ELISPOT) and the major histocompatibility complex (MHC) tetramer assay, and to determine the functionality of these cells by intracellular cytokine staining.

Outcome Measures

Primary: Overall Survival [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15 ] Recurrence Free Survival [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15 ] Secondary: Overall Survival in Human Leukocyte Antigens-A2 (HLA-A2) Positive Patients [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years,up to year 15 ] Recurrence Free Survival in HLA-A2 Positive Patients [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15 ] 5-year Overall Survival Rate [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15 ] 5-year Recurrence Free Survival Rate [ Time Frame: assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15 ]

NCI Description

This dataset will allow users to reproduce the results reported in the Journal of Clinical Oncology (Henry et al., JCO, 2017), which contains patient-level data (one row per patient), including eligibility, evaluability, treatment, demographic, and baseline information.

Clinical Trial Title

A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer

Trial Summary and Conditions

RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy. PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Primary To assess whether daily duloxetine hydrochloride (duloxetine) decreases average joint pain in women with aromatase inhibitor-associated musculoskeletal syndrome (AIMSS), as measured at 12 weeks by the modified Brief Pain Inventory Short Form (BPI-SF). Secondary To assess whether daily duloxetine decreases worst joint pain in women with AIMSS, as measured at 12 weeks by the modified BPI-SF. To assess whether daily duloxetine decreases pain interference in women with AIMSS, as measured at 12 weeks by the modified BPI-SF. To investigate whether daily duloxetine improves functioning, pain, and stiffness in the knees/hips according to the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scale. (Exploratory) To investigate whether daily duloxetine improves function, pain, and stiffness in the hands according to the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH). (Exploratory) To investigate whether daily duloxetine improves functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES). (Exploratory) To investigate whether daily duloxetine improves the proportion of patients reporting changes for the better versus worst as measured by the Global Rating of Change Scale. (Exploratory) To investigate whether daily duloxetine decreases analgesic use. To investigate whether daily duloxetine increases adherence to, and reduces the discontinuation rate for, aromatase inhibitor (AI) therapy. (Exploratory) To assess whether patients receiving duloxetine as compared to placebo have improved depression as measured by the Patient Health Questionnaire (PHQ-9) at Weeks 6 and 12. (Exploratory) To explore the relationship between inherited variants in genes responsible for duloxetine metabolism and activity (COMT, HTR3A, SLC6A2, SLC6A4, CYP1A2, CYP2D6) and aromatase (CYP19A1) and change in pain with 12 weeks of treatment. (Exploratory)

Outcome Measures

Primary: Average Joint Pain According to BPI-SF [ Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported ] Secondary: Worst Joint Pain According to the BPI-SF [ Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported ] Pain Interference According to the BPI-SF [ Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported ]

NCI Description

This dataset will allow users to reproduce the results reported in the Journal of Clinical Oncology (Henry et al., JCO, 2017), which contains event-level information (one row per patient per adverse event experienced on trial).

Clinical Trial Title

A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer

Trial Summary and Conditions

RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy. PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Primary To assess whether daily duloxetine hydrochloride (duloxetine) decreases average joint pain in women with aromatase inhibitor-associated musculoskeletal syndrome (AIMSS), as measured at 12 weeks by the modified Brief Pain Inventory Short Form (BPI-SF). Secondary To assess whether daily duloxetine decreases worst joint pain in women with AIMSS, as measured at 12 weeks by the modified BPI-SF. To assess whether daily duloxetine decreases pain interference in women with AIMSS, as measured at 12 weeks by the modified BPI-SF. To investigate whether daily duloxetine improves functioning, pain, and stiffness in the knees/hips according to the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scale. (Exploratory) To investigate whether daily duloxetine improves function, pain, and stiffness in the hands according to the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH). (Exploratory) To investigate whether daily duloxetine improves functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES). (Exploratory) To investigate whether daily duloxetine improves the proportion of patients reporting changes for the better versus worst as measured by the Global Rating of Change Scale. (Exploratory) To investigate whether daily duloxetine decreases analgesic use. To investigate whether daily duloxetine increases adherence to, and reduces the discontinuation rate for, aromatase inhibitor (AI) therapy. (Exploratory) To assess whether patients receiving duloxetine as compared to placebo have improved depression as measured by the Patient Health Questionnaire (PHQ-9) at Weeks 6 and 12. (Exploratory) To explore the relationship between inherited variants in genes responsible for duloxetine metabolism and activity (COMT, HTR3A, SLC6A2, SLC6A4, CYP1A2, CYP2D6) and aromatase (CYP19A1) and change in pain with 12 weeks of treatment. (Exploratory)

Outcome Measures

Primary: Average Joint Pain According to BPI-SF [ Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported ] Secondary: Worst Joint Pain According to the BPI-SF [ Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported ] Pain Interference According to the BPI-SF [ Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported ]

NCI Description

This dataset will allow users to reproduce the results reported in the Journal of Clinical Oncology (Henry et al., JCO, 2017), which contains assessment-level data (one row per patient per planned assessment time), including scores for each of the patient-completed questionnaires, days from registration to time of assessment, and whether the questionnaires were completed within the protocol-mandated time frame.

Clinical Trial Title

A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer

Trial Summary and Conditions

RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy. PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Primary To assess whether daily duloxetine hydrochloride (duloxetine) decreases average joint pain in women with aromatase inhibitor-associated musculoskeletal syndrome (AIMSS), as measured at 12 weeks by the modified Brief Pain Inventory Short Form (BPI-SF). Secondary To assess whether daily duloxetine decreases worst joint pain in women with AIMSS, as measured at 12 weeks by the modified BPI-SF. To assess whether daily duloxetine decreases pain interference in women with AIMSS, as measured at 12 weeks by the modified BPI-SF. To investigate whether daily duloxetine improves functioning, pain, and stiffness in the knees/hips according to the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scale. (Exploratory) To investigate whether daily duloxetine improves function, pain, and stiffness in the hands according to the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH). (Exploratory) To investigate whether daily duloxetine improves functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES). (Exploratory) To investigate whether daily duloxetine improves the proportion of patients reporting changes for the better versus worst as measured by the Global Rating of Change Scale. (Exploratory) To investigate whether daily duloxetine decreases analgesic use. To investigate whether daily duloxetine increases adherence to, and reduces the discontinuation rate for, aromatase inhibitor (AI) therapy. (Exploratory) To assess whether patients receiving duloxetine as compared to placebo have improved depression as measured by the Patient Health Questionnaire (PHQ-9) at Weeks 6 and 12. (Exploratory) To explore the relationship between inherited variants in genes responsible for duloxetine metabolism and activity (COMT, HTR3A, SLC6A2, SLC6A4, CYP1A2, CYP2D6) and aromatase (CYP19A1) and change in pain with 12 weeks of treatment. (Exploratory)

Outcome Measures

Primary: Average Joint Pain According to BPI-SF [ Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported ] Secondary: Worst Joint Pain According to the BPI-SF [ Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported ] Pain Interference According to the BPI-SF [ Time Frame: Weeks 2, 6, 12, and 24; Week 12 reported ]

NCI Description

Dataset 2 Description: NCT01230983-D2 is the subset of the 239 patients with data on Troponin levels. These data were used in the mixed model analyses to assess the effect of Dexrazoxane on the probability of an elevated troponin concentration during treatment.

Clinical Trial Title

Intensive Treatment For T-CELL Acute Lymphoblastic Leukemia and Advanced Stage Lymphoblastic Non-Hodgkin's Lymphoma: A Pediatric Oncology Group Phase III Study

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Dexrazoxane may lessen the side effects of chemotherapy. PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without dexrazoxane and with or without high-dose methotrexate in patients with acute lymphoblastic leukemia or advanced lymphoblastic non-Hodgkin's lymphoma.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: I. Determine, in a randomized trial, the effectiveness of high-dose methotrexate when added to a multiagent chemotherapy backbone (the Dana Farber Cancer Institute regimen, protocol DFCI-87001) proven effective in T-cell acute lymphoblastic leukemia (T-ALL) and advanced lymphoblastic non-Hodgkin's lymphoma (NHL). II. Determine the role of dexrazoxane in preventing cardiotoxicity in children with T-ALL and advanced lymphoblastic NHL treated with an anthracycline-based regimen. III. Study the biology of T-cell lymphoid malignancies by accumulating data on the concurrent ALL classification study (POG-9400) and analyzing the data relative to outcome. IV. Evaluate the correlation of minimal residual disease (using the TAL 1 proto-oncogene) with event-free survival. V. Determine the role of p53 and p16 tumor suppressor genes in T-ALL. VI. Determine whether drug sensitivity profiles of blast cells to doxorubicin, methotrexate, and cytarabine correlate with initial response and subsequent relapse. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease category (acute lymphoblastic leukemia (ALL) with no CNS disease vs. ALL with CNS disease vs. non-Hodgkin's lymphoma (NHL) with no CNS disease vs. NHL with CNS disease), gender, race (Caucasian vs. African American vs. Hispanic). Patients are randomized to one of four treatment arms.

Outcome Measures

Primary: Complete Continuous Remission [ Time Frame: Time to failure for any cause among patients achieving a complete response ] Secondary: Abnormalities in the 31 week and the year 3 echocardiograms [ Time Frame: 1 year off therapy ]

NCI Description

Dataset 1 Description: NCT01230983-D1 includes all patients enrolled on the study. This dataset will allow users to reproduce all analyses presented in the manuscript both overall and comparison of the Doxorubicin versus Doxorubicin + Dexrazoxane arms.

Clinical Trial Title

Intensive Treatment For T-CELL Acute Lymphoblastic Leukemia and Advanced Stage Lymphoblastic Non-Hodgkin's Lymphoma: A Pediatric Oncology Group Phase III Study

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Dexrazoxane may lessen the side effects of chemotherapy. PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without dexrazoxane and with or without high-dose methotrexate in patients with acute lymphoblastic leukemia or advanced lymphoblastic non-Hodgkin's lymphoma.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: I. Determine, in a randomized trial, the effectiveness of high-dose methotrexate when added to a multiagent chemotherapy backbone (the Dana Farber Cancer Institute regimen, protocol DFCI-87001) proven effective in T-cell acute lymphoblastic leukemia (T-ALL) and advanced lymphoblastic non-Hodgkin's lymphoma (NHL). II. Determine the role of dexrazoxane in preventing cardiotoxicity in children with T-ALL and advanced lymphoblastic NHL treated with an anthracycline-based regimen. III. Study the biology of T-cell lymphoid malignancies by accumulating data on the concurrent ALL classification study (POG-9400) and analyzing the data relative to outcome. IV. Evaluate the correlation of minimal residual disease (using the TAL 1 proto-oncogene) with event-free survival. V. Determine the role of p53 and p16 tumor suppressor genes in T-ALL. VI. Determine whether drug sensitivity profiles of blast cells to doxorubicin, methotrexate, and cytarabine correlate with initial response and subsequent relapse. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease category (acute lymphoblastic leukemia (ALL) with no CNS disease vs. ALL with CNS disease vs. non-Hodgkin's lymphoma (NHL) with no CNS disease vs. NHL with CNS disease), gender, race (Caucasian vs. African American vs. Hispanic). Patients are randomized to one of four treatment arms.

Outcome Measures

Primary: Complete Continuous Remission [ Time Frame: Time to failure for any cause among patients achieving a complete response ] Secondary: Abnormalities in the 31 week and the year 3 echocardiograms [ Time Frame: 1 year off therapy ]

NCI Description

The NCT00003594_D4end_at dataset is one of 4 datasets associated with PubMed ID 14665611. This dataset contains information per patient regarding end of treatment timing and reason. Note: These datasets have been updated since the primary publication and may not match the exact results reported in the primary manuscript.

Clinical Trial Title

A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is most effective in treating advanced colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have advanced, recurrent, or metastatic colorectal cancer that cannot be treated with surgery or radiation therapy.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Compare the time to progression in patients with locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma treated with combinations of oxaliplatin, fluorouracil, leucovorin calcium, and irinotecan. Compare the quality of life, response rate, time to treatment failure, and overall survival in patients treated with these regimens. Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior adjuvant chemotherapy (yes vs no), prior immunotherapy (yes vs no), and age (under 65 vs 65 and over). Patients are randomized to one of three treatment arms. Only arm II remains open to accrual. Arm I (Saltz regimen): Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks followed by 2 weeks of rest. Courses repeat every 6 weeks. (Arm I closed to accrual as of March 15, 2002.) Arm II (FOLFOX4 regimen): Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Arm III (oxaliplatin plus irinotecan): Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on day 1. Courses repeat every 3 weeks. (Arm III closed to accrual as of March 15, 2002.) Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 825 patients (275 per arm) have been accrued for this study thus far. Additional patients are being accrued on arm II. (Arms I and III closed to accrual as of March 15, 2002.)

Outcome Measures

Primary: time to progression [ Time Frame: Up to 5 years ] Secondary: overall survival [ Time Frame: Up to 5 years ] time to treatment failure [ Time Frame: Up to 5 years ] response rate [ Time Frame: Up to 5 years ] quality of life [ Time Frame: Up to 5 years ]

NCI Description

The NCT00003594_D3cytox dataset is one of 4 datasets associated with PubMed ID 14665611. This dataset contains information per patient, per cycle, per adverse event during treatment. Note: These datasets have been updated since the primary publication and may not match the exact results reported in the primary manuscript.

Clinical Trial Title

A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is most effective in treating advanced colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have advanced, recurrent, or metastatic colorectal cancer that cannot be treated with surgery or radiation therapy.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Compare the time to progression in patients with locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma treated with combinations of oxaliplatin, fluorouracil, leucovorin calcium, and irinotecan. Compare the quality of life, response rate, time to treatment failure, and overall survival in patients treated with these regimens. Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior adjuvant chemotherapy (yes vs no), prior immunotherapy (yes vs no), and age (under 65 vs 65 and over). Patients are randomized to one of three treatment arms. Only arm II remains open to accrual. Arm I (Saltz regimen): Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks followed by 2 weeks of rest. Courses repeat every 6 weeks. (Arm I closed to accrual as of March 15, 2002.) Arm II (FOLFOX4 regimen): Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Arm III (oxaliplatin plus irinotecan): Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on day 1. Courses repeat every 3 weeks. (Arm III closed to accrual as of March 15, 2002.) Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 825 patients (275 per arm) have been accrued for this study thus far. Additional patients are being accrued on arm II. (Arms I and III closed to accrual as of March 15, 2002.)

Outcome Measures

Primary: time to progression [ Time Frame: Up to 5 years ] Secondary: overall survival [ Time Frame: Up to 5 years ] time to treatment failure [ Time Frame: Up to 5 years ] response rate [ Time Frame: Up to 5 years ] quality of life [ Time Frame: Up to 5 years ]

NCI Description

The NCT00003594_D2cycle dataset is one of 4 datasets associated with PubMed ID 14665611. This dataset contains information per patient, per cycle regarding dosing and overall response assessment status. Note: These datasets have been updated since the primary publication and may not match the exact results reported in the primary manuscript.

Clinical Trial Title

A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is most effective in treating advanced colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have advanced, recurrent, or metastatic colorectal cancer that cannot be treated with surgery or radiation therapy.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Compare the time to progression in patients with locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma treated with combinations of oxaliplatin, fluorouracil, leucovorin calcium, and irinotecan. Compare the quality of life, response rate, time to treatment failure, and overall survival in patients treated with these regimens. Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior adjuvant chemotherapy (yes vs no), prior immunotherapy (yes vs no), and age (under 65 vs 65 and over). Patients are randomized to one of three treatment arms. Only arm II remains open to accrual. Arm I (Saltz regimen): Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks followed by 2 weeks of rest. Courses repeat every 6 weeks. (Arm I closed to accrual as of March 15, 2002.) Arm II (FOLFOX4 regimen): Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Arm III (oxaliplatin plus irinotecan): Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on day 1. Courses repeat every 3 weeks. (Arm III closed to accrual as of March 15, 2002.) Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 825 patients (275 per arm) have been accrued for this study thus far. Additional patients are being accrued on arm II. (Arms I and III closed to accrual as of March 15, 2002.)

Outcome Measures

Primary: time to progression [ Time Frame: Up to 5 years ] Secondary: overall survival [ Time Frame: Up to 5 years ] time to treatment failure [ Time Frame: Up to 5 years ] response rate [ Time Frame: Up to 5 years ] quality of life [ Time Frame: Up to 5 years ]

NCI Description

The NCT00003594_D1crse dataset is one of 4 datasets associated with PubMed ID 14665611. This dataset contains information regarding patient-level information including eligibility, baseline characteristics, and best response. It also includes information to analyze overall survival and time to progression.

Clinical Trial Title

A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is most effective in treating advanced colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have advanced, recurrent, or metastatic colorectal cancer that cannot be treated with surgery or radiation therapy.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Compare the time to progression in patients with locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma treated with combinations of oxaliplatin, fluorouracil, leucovorin calcium, and irinotecan. Compare the quality of life, response rate, time to treatment failure, and overall survival in patients treated with these regimens. Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior adjuvant chemotherapy (yes vs no), prior immunotherapy (yes vs no), and age (under 65 vs 65 and over). Patients are randomized to one of three treatment arms. Only arm II remains open to accrual. Arm I (Saltz regimen): Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks followed by 2 weeks of rest. Courses repeat every 6 weeks. (Arm I closed to accrual as of March 15, 2002.) Arm II (FOLFOX4 regimen): Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Arm III (oxaliplatin plus irinotecan): Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on day 1. Courses repeat every 3 weeks. (Arm III closed to accrual as of March 15, 2002.) Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 825 patients (275 per arm) have been accrued for this study thus far. Additional patients are being accrued on arm II. (Arms I and III closed to accrual as of March 15, 2002.)

Outcome Measures

Primary: time to progression [ Time Frame: Up to 5 years ] Secondary: overall survival [ Time Frame: Up to 5 years ] time to treatment failure [ Time Frame: Up to 5 years ] response rate [ Time Frame: Up to 5 years ] quality of life [ Time Frame: Up to 5 years ]

NCI Description

This dataset contains baseline, efficacy, 13-CRA toxicity, and CTC toxicity data from trial NCT03370367.

Clinical Trial Title

Double Blind Phase III Trial of Effects of Low Dose 13-Cisretinoic Acid on Prevention of Second Primaries in Stages I-II Head and Neck Cancer

Trial Summary and Conditions

In this trial the investigators propose to utilize 13-cRA to prevent dysplastic changes and second malignancies in patients with squamous cell carcinoma of the head and neck regions who have a high probability of cure from their primary cancer. Comparisons between patients treated by 13-cRA and patients receiving placebo will include: 1. The time to diagnosis of second primary for the treatment versus control groups. 2. Survival time for the treatment versus control groups. 3. Secondarily, the cost-benefit ratio for 13-cRA will be analyzed by assessing the toxicities of 13-cis retinoic acid treated patients in comparison to those experienced by placebo treated patients.

Data Summary

See data dictionary for more details.

Study Objectives

Not Provided.

Outcome Measures

Primary: The time to diagnosis of second primary for the treatment versus control groups. [ Time Frame: 20 years ] Secondary: Survival time for the treatment versus control groups. [ Time Frame: 20 years ]

NCI Description

NCT00079001-D3-Dataset.csv (ae) is one of 3 datasets associated with PubMed ID 24590644. This dataset contains information that will allow you to reproduce the toxicity reported.

Clinical Trial Title

A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone

Trial Summary and Conditions

RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases. PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.

Data Summary

See data dictionary for more details.

Study Objectives

Zoledronic acid decreases the risk of skeletal related events in men with prostate cancer metastatic to bone and disease progression after primary hormonal therapy. This study is designed to evaluate whether earlier treatment with zoledronic acid will further decrease the risk of skeletal related events. This is a randomized, double-blind, placebo-controlled, multicenter study followed by an open-label study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior skeletal-related event (no vs yes), and serum alkaline phosphatase (less than upper limit of normal [ULN] vs greater than or equal to ULN). The primary objective of the study is to determine whether treatment with zoledronic acid at the time of initiation of androgen deprivation therapy for metastatic prostate cancer will delay the time to first skeletal related event. The secondary objective of the study is to compare the effect of treatment with zoledronic acid to placebo on overall survival (OS), progression-free survival (PFS) and toxicity in men receiving androgen deprivation therapy for metastatic prostate cancer. Patients are randomized to 1 of 2 treatment arms. Treatment continues in the absence of disease progression or a skeletal-related event. All patients receive concurrent androgen deprivation therapy with a GnRH agonist. Patients also receive oral calcium and (vitamin D) supplements daily. Patients progressing to androgen-independent prostate cancer proceed to the open-label therapy with zoledronic acid IV. Treatment continues for 3 weeks in the absence of disease progression or the first skeletal-related event. Patients are followed periodically for approximately 10 years after entry on the study.

Outcome Measures

Primary: Time to First Skeletal Related Event [ Time Frame: Up to 10 years ] Secondary: Overall Survival [ Time Frame: Up to 10 years ] Progression-free Survival [ Time Frame: Up to 10 years ]

NCI Description

NCT00079001-D2-Dataset.csv (analysis) is one of 3 datasets associated with PubMed ID 24590644. This dataset contains information that will allow you to reproduce the primary analysis and time-to-event analysis.

Clinical Trial Title

A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone

Trial Summary and Conditions

RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases. PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.

Data Summary

See data dictionary for more details.

Study Objectives

Zoledronic acid decreases the risk of skeletal related events in men with prostate cancer metastatic to bone and disease progression after primary hormonal therapy. This study is designed to evaluate whether earlier treatment with zoledronic acid will further decrease the risk of skeletal related events. This is a randomized, double-blind, placebo-controlled, multicenter study followed by an open-label study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior skeletal-related event (no vs yes), and serum alkaline phosphatase (less than upper limit of normal [ULN] vs greater than or equal to ULN). The primary objective of the study is to determine whether treatment with zoledronic acid at the time of initiation of androgen deprivation therapy for metastatic prostate cancer will delay the time to first skeletal related event. The secondary objective of the study is to compare the effect of treatment with zoledronic acid to placebo on overall survival (OS), progression-free survival (PFS) and toxicity in men receiving androgen deprivation therapy for metastatic prostate cancer. Patients are randomized to 1 of 2 treatment arms. Treatment continues in the absence of disease progression or a skeletal-related event. All patients receive concurrent androgen deprivation therapy with a GnRH agonist. Patients also receive oral calcium and (vitamin D) supplements daily. Patients progressing to androgen-independent prostate cancer proceed to the open-label therapy with zoledronic acid IV. Treatment continues for 3 weeks in the absence of disease progression or the first skeletal-related event. Patients are followed periodically for approximately 10 years after entry on the study.

Outcome Measures

Primary: Time to First Skeletal Related Event [ Time Frame: Up to 10 years ] Secondary: Overall Survival [ Time Frame: Up to 10 years ] Progression-free Survival [ Time Frame: Up to 10 years ]

NCI Description

NCT00079001-D1-Dataset.csv (baseline) is one of 3 datasets associated with PubMed ID 24590644. This dataset contains information that will allow you to reproduce the baseline characteristics table.

Clinical Trial Title

A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone

Trial Summary and Conditions

RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases. PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.

Data Summary

See data dictionary for more details.

Study Objectives

Zoledronic acid decreases the risk of skeletal related events in men with prostate cancer metastatic to bone and disease progression after primary hormonal therapy. This study is designed to evaluate whether earlier treatment with zoledronic acid will further decrease the risk of skeletal related events. This is a randomized, double-blind, placebo-controlled, multicenter study followed by an open-label study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior skeletal-related event (no vs yes), and serum alkaline phosphatase (less than upper limit of normal [ULN] vs greater than or equal to ULN). The primary objective of the study is to determine whether treatment with zoledronic acid at the time of initiation of androgen deprivation therapy for metastatic prostate cancer will delay the time to first skeletal related event. The secondary objective of the study is to compare the effect of treatment with zoledronic acid to placebo on overall survival (OS), progression-free survival (PFS) and toxicity in men receiving androgen deprivation therapy for metastatic prostate cancer. Patients are randomized to 1 of 2 treatment arms. Treatment continues in the absence of disease progression or a skeletal-related event. All patients receive concurrent androgen deprivation therapy with a GnRH agonist. Patients also receive oral calcium and (vitamin D) supplements daily. Patients progressing to androgen-independent prostate cancer proceed to the open-label therapy with zoledronic acid IV. Treatment continues for 3 weeks in the absence of disease progression or the first skeletal-related event. Patients are followed periodically for approximately 10 years after entry on the study.

Outcome Measures

Primary: Time to First Skeletal Related Event [ Time Frame: Up to 10 years ] Secondary: Overall Survival [ Time Frame: Up to 10 years ] Progression-free Survival [ Time Frame: Up to 10 years ]

NCI Description

This dataset will allow users to reproduce the primary analysis publication (PubMed ID: 21304082) for study NCT00003855.

Clinical Trial Title

A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node

Trial Summary and Conditions

RATIONALE: Surgery to remove lymph nodes in the armpit may remove cancer cells that have spread from tumors in the breast. PURPOSE: Randomized phase III trial to determine the effectiveness of removing lymph nodes in the armpit in treating women who have stage I or stage IIA breast cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Long term: To assess whether overall survival for patients randomized to Arm 2 (no immediate ALND) is essentially equivalent to (or better than) than that for patients assigned to Arm 1 (completion ALND). Short term: To quantify and compare the surgical morbidities associated with SLND plus ALND versus SLND alone. OUTLINE: This is a randomized study. After segmental mastectomy and sentinel lymph node dissection, patients are stratified according to age (50 and under vs over 50), estrogen receptor status (positive vs negative), and tumor size (no greater than 1 cm vs greater than 1 cm but no greater than 2 cm vs greater than 2 cm). Patients are randomized to one of two treatment arms.

Outcome Measures

Primary: Overall survival [ Time Frame: Up to 10 years ] Morbidity [ Time Frame: Up to 10 years ] Disease-free survival [ Time Frame: Up to 10 years ]

NCI Description

The NCT00003088_D6_(comp_by_cyc) dataset is one of 10 datasets associated with PubMed ID 12668651. This dataset contains data on complications during treatment by cycle. Dataset NCT00003088-D1 and NCT00003088-D6 each contain the same clinical data. NCT00003088-D6 also contains a patient reference (patid) that can be tied to patient information submitted to NCTN Navigator submissions.

Clinical Trial Title

A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at different times or combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: I. Compare the sequential chemotherapy with doxorubicin, paclitaxel and cyclophosphamide to combined doxorubicin and cyclophosphamide followed by paclitaxel for disease free and overall survival in women with node positive stage II or IIIA breast cancer. II. Determine whether increasing the dose density of adjuvant chemotherapy will improve disease free and overall survival. III. Compare the toxicity in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized into one of four arms (sequential chemotherapy every 2 weeks vs every 3 weeks vs concurrent chemotherapy followed by paclitaxel every 2 weeks vs every 3 weeks). All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy plus axillary node dissection. Adjuvant chemotherapy is started within 84 days following the last surgical procedure. Patients undergo radiotherapy 4-6 weeks after the completion of chemotherapy. Patients are followed every 6 months for 5 years, then annually until death.

Outcome Measures

Disease free survival [ Time Frame: 4 years ]

NCI Description

The NCT00003088_D7_(comp_by_pt) dataset is one of 10 datasets associated with PubMed ID 12668651. This dataset contains data on complications during treatment by patient. Dataset NCT00003088-D2 and NCT00003088-D7 each contain the same clinical data. NCT00003088-D7 also contains a patient reference (patid) that can be tied to patient information submitted to NCTN Navigator submissions.

Clinical Trial Title

A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at different times or combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: I. Compare the sequential chemotherapy with doxorubicin, paclitaxel and cyclophosphamide to combined doxorubicin and cyclophosphamide followed by paclitaxel for disease free and overall survival in women with node positive stage II or IIIA breast cancer. II. Determine whether increasing the dose density of adjuvant chemotherapy will improve disease free and overall survival. III. Compare the toxicity in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized into one of four arms (sequential chemotherapy every 2 weeks vs every 3 weeks vs concurrent chemotherapy followed by paclitaxel every 2 weeks vs every 3 weeks). All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy plus axillary node dissection. Adjuvant chemotherapy is started within 84 days following the last surgical procedure. Patients undergo radiotherapy 4-6 weeks after the completion of chemotherapy. Patients are followed every 6 months for 5 years, then annually until death.

Outcome Measures

Disease free survival [ Time Frame: 4 years ]

NCI Description

The NCT00003088_D8_(dosered) dataset is one of 10 datasets associated with PubMed ID 12668651. This dataset contains data on dose reductions. Dataset NCT00003088-D3 and NCT00003088-D8 each contain the same clinical data. NCT00003088-D8 also contains a patient reference (patid) that can be tied to patient information submitted to NCTN Navigator submissions.

Clinical Trial Title

A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at different times or combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: I. Compare the sequential chemotherapy with doxorubicin, paclitaxel and cyclophosphamide to combined doxorubicin and cyclophosphamide followed by paclitaxel for disease free and overall survival in women with node positive stage II or IIIA breast cancer. II. Determine whether increasing the dose density of adjuvant chemotherapy will improve disease free and overall survival. III. Compare the toxicity in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized into one of four arms (sequential chemotherapy every 2 weeks vs every 3 weeks vs concurrent chemotherapy followed by paclitaxel every 2 weeks vs every 3 weeks). All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy plus axillary node dissection. Adjuvant chemotherapy is started within 84 days following the last surgical procedure. Patients undergo radiotherapy 4-6 weeks after the completion of chemotherapy. Patients are followed every 6 months for 5 years, then annually until death.

Outcome Measures

Disease free survival [ Time Frame: 4 years ]

NCI Description

The NCT00003088_D9_(toxicity) dataset is one of 10 datasets associated with PubMed ID 12668651. This dataset contains data used to evaluate major toxicities that occurred during protocol treatment. The dataset contains standard non-hematologic toxicity data for grades 0 to 5 for treated patients. Dataset NCT00003088-D4 and NCT00003088-D9 each contain the same clinical data. NCT00003088-D9 also contains a patient reference (patid) that can be tied to patient information submitted to NCTN Navigator submissions.

Clinical Trial Title

A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at different times or combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: I. Compare the sequential chemotherapy with doxorubicin, paclitaxel and cyclophosphamide to combined doxorubicin and cyclophosphamide followed by paclitaxel for disease free and overall survival in women with node positive stage II or IIIA breast cancer. II. Determine whether increasing the dose density of adjuvant chemotherapy will improve disease free and overall survival. III. Compare the toxicity in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized into one of four arms (sequential chemotherapy every 2 weeks vs every 3 weeks vs concurrent chemotherapy followed by paclitaxel every 2 weeks vs every 3 weeks). All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy plus axillary node dissection. Adjuvant chemotherapy is started within 84 days following the last surgical procedure. Patients undergo radiotherapy 4-6 weeks after the completion of chemotherapy. Patients are followed every 6 months for 5 years, then annually until death.

Outcome Measures

Disease free survival [ Time Frame: 4 years ]

NCI Description

The NCT00003088_D10_(treated) dataset is one of 5 datasets associated with PubMed ID 12668651. This dataset contains one record for treated patients only (N=1973). The dataset contains the primary and secondary endpoint survival data. Dataset NCT00003088-D5 and NCT00003088-D10 each contain the same clinical data. NCT00003088-D10 also contains a patient reference (patid) that can be tied to patient information submitted to NCTN Navigator submissions.

Clinical Trial Title

A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at different times or combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: I. Compare the sequential chemotherapy with doxorubicin, paclitaxel and cyclophosphamide to combined doxorubicin and cyclophosphamide followed by paclitaxel for disease free and overall survival in women with node positive stage II or IIIA breast cancer. II. Determine whether increasing the dose density of adjuvant chemotherapy will improve disease free and overall survival. III. Compare the toxicity in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized into one of four arms (sequential chemotherapy every 2 weeks vs every 3 weeks vs concurrent chemotherapy followed by paclitaxel every 2 weeks vs every 3 weeks). All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy plus axillary node dissection. Adjuvant chemotherapy is started within 84 days following the last surgical procedure. Patients undergo radiotherapy 4-6 weeks after the completion of chemotherapy. Patients are followed every 6 months for 5 years, then annually until death.

Outcome Measures

Disease free survival [ Time Frame: 4 years ]

NCI Description

This dataset will allow users to reproduce the analysis for the primary publication in trial NCT00726622. This dataset is identical to NCT00726622-D1 except it also includes a patient reference (patref) field that can be tied to patient information submitted to NCTN Navigator submissions.

Clinical Trial Title

A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Resection Versus Open Resection for Rectal Cancer

Trial Summary and Conditions

This study is being done to compare two types of surgery currently used for rectal cancer. The two types of surgery are laparoscopic-assisted rectal resection and open laparotomy rectal resection. Although laparoscopic-assisted rectal resection is being used for rectal cancer in some medical centers, the effectiveness of this type of surgery compared to open surgery is unknown. The study will compare the safety and effectiveness of the surgeries, recovery from surgery in the hospital, overall recovery from surgery and cancer outcome.

Data Summary

See data dictionary for more details.

Study Objectives

This is a multicenter study. Patients eligible for this trial will have completed 5FU based neoadjuvant chemotherapy/radiation therapy per the institution's standard of care or IRB approved clinical trial. Patients may be registered/randomized anytime after completion of neoadjuvant therapy, but surgery must occur within 4-12 weeks (28-84 days) after completion of neoadjuvant therapy. Patients are stratified according to the site of the primary tumor (high, middle or low rectum), registering surgeon, and planned operative procedure (low anterior resection or abdominal perineal resection). Patients are randomized to 1 of 2 treatment arms. Please see the arms section for more details. The primary and secondary objectives are listed below. Primary Objective: To test the hypothesis that laparoscopic-assisted resection for rectal cancer is not inferior to open rectal resection, based on a composite primary endpoint of oncologic factors which are indicative of a safe and feasible operation. Secondary Objectives: To assess patient-related benefit of laparoscopic-assisted resection for rectal cancer vs. open rectal resection (blood loss, length of stay, pain medicine utilization) To assess disease free survival and local pelvic recurrence at two years. To assess quality of life, sexual function, bowel and stoma function at scheduled time points throughout the trial. Patients will be evaluated after surgery to determine the need for subsequent care based on the final pathology. Patients should not start treatment on any other investigative trial involving intervention or invasive diagnostic procedures less than or equal to 30 days following surgery to enable a complete evaluation of post-operative adverse events and complications occurring within 30 days of surgery. Patients are followed periodically for up to 5 years post surgery.

Outcome Measures

PRIMARY Comparing Laparoscopic-assisted Resection to Open Rectal Resection for Rectal Cancer as Measured by the Percentage of Patients With Successful Resection Based on Pathological Evaluation. [ Time Frame: At time of Surgery ] Primary endpoint parameters: Circumferential margin > 1 mm Negative distal margin Completeness of total mesorectal excision (TME) All three criteria must be met for a resection to be deemed adequate. Laparoscopic-assisted resection will be compared to Open rectal resection to determine if it is non-inferior. SECONDARY Completeness of Total Mesorectal Excision (Complete or Nearly Complete) [ Time Frame: At time of surgery ] Negative Distal Resected Margin [ Time Frame: At time of surgery ] Circumferential Margin > 1 mm [ Time Frame: At time of surgery ] Length of Stay [ Time Frame: Two weeks post-surgery ] Use of Pain Medication [ Time Frame: Two weeks post-surgery ] Operative Times [ Time Frame: During surgery ] Disease-free Survival [ Time Frame: Up to 2 years post surgery ] Local Pelvic Recurrence Rates [ Time Frame: Up to 2 years post surgery ] Overall Survival [ Time Frame: Up to 5 years post surgery ] Quality of Life and Sexual Function [ Time Frame: Up to 5 years post surgery ] Bowel Function [ Time Frame: Up to 5 years post surgery ] Bowel and Stoma Function [ Time Frame: Up to 5 years post surgery ]

NCI Description

There are three different submissions (each for one dataset) for trial NCT00602641. This data submission, NCT00602641-D2, contains data for treatment dose. The other two data submissions, NCT00602641-D1 and NCT00602641-D3, contain clinical data together with QOL data and toxicity data, respectively.

Clinical Trial Title

An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid?) (MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy

Trial Summary and Conditions

This randomized phase III trial studies melphalan and prednisone with thalidomide to see how well it works compared to melphalan and prednisone together with lenalidomide in treating patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as melphalan and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It is not yet known whether melphalan and prednisone are more effective when given together with thalidomide or lenalidomide in treating multiple myeloma.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To compare progression-free survival between patients receiving melphalan, prednisone, and thalidomide versus melphalan, prednisone, and lenalidomide in newly diagnosed multiple myeloma patients who are not candidates for high-dose therapy. SECONDARY OBJECTIVES: I. To compare overall survival between the arms. II. To compare response rates and depth of response. III. To compare the incidence of toxicities. IV. To validate the translocation (TC) classification of myeloma as a prognostic tool using gene expression profiling at diagnosis. TERTIARY OBJECTIVES: I. To compare quality-of-life (QOL) change between arms based on the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-Ntx) Trial Outcome Index (TOI) from baseline to the end of course 24 (maintenance therapy). II. To examine the impact of differential treatment responses, if observed, on QOL based on the FACT-Ntx TOI up to cycle 38 (maintenance therapy). III. To obtain prospective data on myeloma specific QOL attributes. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: INDUCTION THERAPY: Patients receive melphalan orally (PO) and prednisone PO once daily (QD) on days 1-4, and thalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO QD and continue in the absence of disease progression. ARM II: INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO QD on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression. After completion of study treatment, patients will be followed periodically for 10 years.

Outcome Measures

Primary: Progression-Free Survival (PFS) [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization. ] Secondary: Overall Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization. ] Very Good Partial Response (VGPR) Rate [ Time Frame: Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry. ] Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12 [ Time Frame: Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit. ]

NCI Description

There are three different submissions (each for one dataset) for trial NCT00602641. This data submission, NCT00602641-D1, contains clinical data together with QOL data. The other two data submissions, NCT00602641-D2 and NCT00602641-D3, contain data for treatment dose and toxicity, respectively.

Clinical Trial Title

An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid?) (MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy

Trial Summary and Conditions

This randomized phase III trial studies melphalan and prednisone with thalidomide to see how well it works compared to melphalan and prednisone together with lenalidomide in treating patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as melphalan and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It is not yet known whether melphalan and prednisone are more effective when given together with thalidomide or lenalidomide in treating multiple myeloma.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To compare progression-free survival between patients receiving melphalan, prednisone, and thalidomide versus melphalan, prednisone, and lenalidomide in newly diagnosed multiple myeloma patients who are not candidates for high-dose therapy. SECONDARY OBJECTIVES: I. To compare overall survival between the arms. II. To compare response rates and depth of response. III. To compare the incidence of toxicities. IV. To validate the translocation (TC) classification of myeloma as a prognostic tool using gene expression profiling at diagnosis. TERTIARY OBJECTIVES: I. To compare quality-of-life (QOL) change between arms based on the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-Ntx) Trial Outcome Index (TOI) from baseline to the end of course 24 (maintenance therapy). II. To examine the impact of differential treatment responses, if observed, on QOL based on the FACT-Ntx TOI up to cycle 38 (maintenance therapy). III. To obtain prospective data on myeloma specific QOL attributes. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: INDUCTION THERAPY: Patients receive melphalan orally (PO) and prednisone PO once daily (QD) on days 1-4, and thalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO QD and continue in the absence of disease progression. ARM II: INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO QD on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression. After completion of study treatment, patients will be followed periodically for 10 years.

Outcome Measures

Primary: Progression-Free Survival (PFS) [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization. ] Secondary: Overall Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization. ] Very Good Partial Response (VGPR) Rate [ Time Frame: Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry. ] Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12 [ Time Frame: Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit. ]

NCI Description

There are three different submissions (each for one dataset) for trial NCT00602641. This data submission, NCT00602641-D3, contains toxicity data. The other two data submissions, NCT00602641-D1 and NCT00602641-D2, contain clinical data together with QOL data and data for treatment dose, respectively.

Clinical Trial Title

An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid?) (MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy

Trial Summary and Conditions

This randomized phase III trial studies melphalan and prednisone with thalidomide to see how well it works compared to melphalan and prednisone together with lenalidomide in treating patients with newly diagnosed multiple myeloma. Drugs used in chemotherapy, such as melphalan and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide and lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It is not yet known whether melphalan and prednisone are more effective when given together with thalidomide or lenalidomide in treating multiple myeloma.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To compare progression-free survival between patients receiving melphalan, prednisone, and thalidomide versus melphalan, prednisone, and lenalidomide in newly diagnosed multiple myeloma patients who are not candidates for high-dose therapy. SECONDARY OBJECTIVES: I. To compare overall survival between the arms. II. To compare response rates and depth of response. III. To compare the incidence of toxicities. IV. To validate the translocation (TC) classification of myeloma as a prognostic tool using gene expression profiling at diagnosis. TERTIARY OBJECTIVES: I. To compare quality-of-life (QOL) change between arms based on the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-Ntx) Trial Outcome Index (TOI) from baseline to the end of course 24 (maintenance therapy). II. To examine the impact of differential treatment responses, if observed, on QOL based on the FACT-Ntx TOI up to cycle 38 (maintenance therapy). III. To obtain prospective data on myeloma specific QOL attributes. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: INDUCTION THERAPY: Patients receive melphalan orally (PO) and prednisone PO once daily (QD) on days 1-4, and thalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO QD and continue in the absence of disease progression. ARM II: INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO QD on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression. After completion of study treatment, patients will be followed periodically for 10 years.

Outcome Measures

Primary: Progression-Free Survival (PFS) [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization. ] Secondary: Overall Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization. ] Very Good Partial Response (VGPR) Rate [ Time Frame: Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry. ] Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12 [ Time Frame: Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit. ]

NCI Description

This dataset will allow users to reproduce toxicity analyses reported in the Journal of Clinical Oncology (Yao et al., JCO, 2017, PMID referenced above), which included adverse events among patients with advanced NETs in the SWOG Phase III trial, S0518 (NCT00569127), receiving bevacizumab + octreotide or interferon alfa-2b + octreotide.

Clinical Trial Title

Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor

Trial Summary and Conditions

This randomized phase III trial is studying giving octreotide acetate together with recombinant interferon alfa-2b to see how well it works compared with giving octreotide acetate together with bevacizumab in treating patients with metastatic or locally advanced, high-risk neuroendocrine tumor. Octreotide acetate and recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving octreotide acetate together with recombinant interferon alfa-2b is more effective than giving octreotide acetate together with bevacizumab in treating patients with neuroendocrine tumor.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To compare central review-based progression-free survival in poor prognosis carcinoid patients treated with either depot octreotide (octreotide acetate) plus bevacizumab, or depot octreotide plus interferon (recombinant interferon alfa-2b). II. To compare overall survival, time to treatment failure and traditionally reported progression-free survival in poor prognosis carcinoid patients treated with either depot octreotide plus bevacizumab, or depot octreotide plus interferon. III. To compare objective response (confirmed and unconfirmed CR and PR) in poor prognosis carcinoid patients treated with either depot octreotide plus bevacizumab, or depot octreotide plus interferon. IV. To compare the toxicity profile of patients treated with these two regimens. V. To assess the prognostic and predictive value of VEGF expression in relation to progression-free survival and treatment effect. VI. To compare response of 5HIAA, chromogranin A and neuronspecific enolase among patients with elevated levels at baseline between patients treated with octreotide plus interferon versus octreotide plus bevacizumab. VII. To assess and compare the prognostic and predictive value of the combination of In-111 pentetreotide somatostatin-receptor scintigraphy (SRS) and CT vs. CT in relation to progression-free survival (PFS). VIII. To assess and compare the prognostic and predictive value of the combination of SRS and CT vs. CT in relation to overall survival (OS) and time to treatment failure (TTF). OUTLINE: This is a multicenter study. Patients are stratified according to site of disease (small bowel vs cecum vs appendix vs other site), disease progression after initial diagnosis (yes or no), histologic grade (low vs intermediate [atypical]), and prior octreotide acetate therapy within the past 2 months (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Outcome Measures

Primary: Central Review-based Progression-Free Survival [ Time Frame: Up to 3 years ] Secondary: Overall Survival [ Time Frame: Up to 7 years ] Time to Treatment Failure [ Time Frame: Up to 3 years ] Local Progression-Free Survival (Investigator Assessed) [ Time Frame: Up to 3 years ] Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) [ Time Frame: Up to 3 years ] Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: Up to 3 years ]

NCI Description

This dataset will allow users to reproduce efficacy analyses reported in the Journal of Clinical Oncology (Yao et al., JCO, 2017, PMID referenced above), which included results evaluating bevacizumab or interferon alfa-2b added to octreotide among patients with advanced NETs in the SWOG Phase III trial, S0518 (NCT00569127).

Clinical Trial Title

Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor

Trial Summary and Conditions

This randomized phase III trial is studying giving octreotide acetate together with recombinant interferon alfa-2b to see how well it works compared with giving octreotide acetate together with bevacizumab in treating patients with metastatic or locally advanced, high-risk neuroendocrine tumor. Octreotide acetate and recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving octreotide acetate together with recombinant interferon alfa-2b is more effective than giving octreotide acetate together with bevacizumab in treating patients with neuroendocrine tumor.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To compare central review-based progression-free survival in poor prognosis carcinoid patients treated with either depot octreotide (octreotide acetate) plus bevacizumab, or depot octreotide plus interferon (recombinant interferon alfa-2b). II. To compare overall survival, time to treatment failure and traditionally reported progression-free survival in poor prognosis carcinoid patients treated with either depot octreotide plus bevacizumab, or depot octreotide plus interferon. III. To compare objective response (confirmed and unconfirmed CR and PR) in poor prognosis carcinoid patients treated with either depot octreotide plus bevacizumab, or depot octreotide plus interferon. IV. To compare the toxicity profile of patients treated with these two regimens. V. To assess the prognostic and predictive value of VEGF expression in relation to progression-free survival and treatment effect. VI. To compare response of 5HIAA, chromogranin A and neuronspecific enolase among patients with elevated levels at baseline between patients treated with octreotide plus interferon versus octreotide plus bevacizumab. VII. To assess and compare the prognostic and predictive value of the combination of In-111 pentetreotide somatostatin-receptor scintigraphy (SRS) and CT vs. CT in relation to progression-free survival (PFS). VIII. To assess and compare the prognostic and predictive value of the combination of SRS and CT vs. CT in relation to overall survival (OS) and time to treatment failure (TTF). OUTLINE: This is a multicenter study. Patients are stratified according to site of disease (small bowel vs cecum vs appendix vs other site), disease progression after initial diagnosis (yes or no), histologic grade (low vs intermediate [atypical]), and prior octreotide acetate therapy within the past 2 months (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Outcome Measures

Primary: Central Review-based Progression-Free Survival [ Time Frame: Up to 3 years ] Secondary: Overall Survival [ Time Frame: Up to 7 years ] Time to Treatment Failure [ Time Frame: Up to 3 years ] Local Progression-Free Survival (Investigator Assessed) [ Time Frame: Up to 3 years ] Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) [ Time Frame: Up to 3 years ] Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: Up to 3 years ]

NCI Description

This dataset will allow users to reproduce adverse event tables in trial NCT00533949.

Clinical Trial Title

A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer

Trial Summary and Conditions

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy with or without cetuximab in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation therapy given together with chemotherapy with or without cetuximab to see how well they work in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Primary To compare the overall survival of patients with newly diagnosed, unresectable stage IIIA or IIIB non-small cell lung cancer treated with high- versus standard-dose conformal radiotherapy with concurrent and consolidation chemotherapy comprising carboplatin and paclitaxel. To compare the overall survival of patients treated with versus without cetuximab in the setting of concurrent chemotherapy Secondary To compare progression-free survival and local-regional tumor control in patients treated with these regimens. To compare the toxicity of high- versus standard-dose conformal radiotherapy and concurrent chemotherapy with versus without cetuximab in these patients. To investigate the prognostic and predictive effects of gross tumor volume on overall survival of patients treated with these regimens. To compare the quality of life of patients treated with these regimens. To correlate outcomes (i.e., survival, toxicity, or QOL) in these patients with biological parameters. To analyze the predictive value of pre-treatment standardized uptake value (SUV) of positron emission tomography (PET) scan in predicting survival, distant metastasis, and local-regional control in patients treated with these regimens. To explore biological markers to predict clinical outcome including survival, distant metastasis, local-regional control, and QOL (including toxicity) in patients treated with these regimens. To prospectively collect and bank tissue, blood, and urine specimens for future biomarker analyses in predicting clinical outcome in patients treated with these regimens. To investigate associations between epidermal growth factor receptor (EGFR) expression and toxicity, response, overall survival, and progression-free survival.

Outcome Measures

Primary: Overall Survival Secondary: Progression-free Survival Local-regional Failure (Reported as Two-year Estimates) Percentage of Participants With Grade 3-5 Esophagitis and Pneumonitis Adverse Events as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 Percentage of Participants With Other Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0 Death During or Within 30 Days of Discontinuation of Protocol Treatment Percentage of Patients With Decline From Baseline to 3 Months in the Lung Cancer Subscale (LCS) of the Functional Assessment of the Cancer Therapy Trial Outcome Index (FACT-TOI). Patient-reported Swallowing Ability Quality-adjusted Survival Based on EuroQoL (EQ5D)-Derived Health Utility Score Correlation of Tumor Markers With Overall Survival, Local-regional Failure, and QOL Prognostic and Predictive Effects of Gross Tumor Volume on Overall Survival

NCI Description

This dataset will allow users to reproduce the adverse event tables in trial NCT00533949.

Clinical Trial Title

A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer

Trial Summary and Conditions

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy with or without cetuximab in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation therapy given together with chemotherapy with or without cetuximab to see how well they work in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Primary To compare the overall survival of patients with newly diagnosed, unresectable stage IIIA or IIIB non-small cell lung cancer treated with high- versus standard-dose conformal radiotherapy with concurrent and consolidation chemotherapy comprising carboplatin and paclitaxel. To compare the overall survival of patients treated with versus without cetuximab in the setting of concurrent chemotherapy Secondary To compare progression-free survival and local-regional tumor control in patients treated with these regimens. To compare the toxicity of high- versus standard-dose conformal radiotherapy and concurrent chemotherapy with versus without cetuximab in these patients. To investigate the prognostic and predictive effects of gross tumor volume on overall survival of patients treated with these regimens. To compare the quality of life of patients treated with these regimens. To correlate outcomes (i.e., survival, toxicity, or QOL) in these patients with biological parameters. To analyze the predictive value of pre-treatment standardized uptake value (SUV) of positron emission tomography (PET) scan in predicting survival, distant metastasis, and local-regional control in patients treated with these regimens. To explore biological markers to predict clinical outcome including survival, distant metastasis, local-regional control, and QOL (including toxicity) in patients treated with these regimens. To prospectively collect and bank tissue, blood, and urine specimens for future biomarker analyses in predicting clinical outcome in patients treated with these regimens. To investigate associations between epidermal growth factor receptor (EGFR) expression and toxicity, response, overall survival, and progression-free survival.

Outcome Measures

Primary: Overall Survival Secondary: Progression-free Survival Local-regional Failure (Reported as Two-year Estimates) Percentage of Participants With Grade 3-5 Esophagitis and Pneumonitis Adverse Events as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 Percentage of Participants With Other Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0 Death During or Within 30 Days of Discontinuation of Protocol Treatment Percentage of Patients With Decline From Baseline to 3 Months in the Lung Cancer Subscale (LCS) of the Functional Assessment of the Cancer Therapy Trial Outcome Index (FACT-TOI). Patient-reported Swallowing Ability Quality-adjusted Survival Based on EuroQoL (EQ5D)-Derived Health Utility Score Correlation of Tumor Markers With Overall Survival, Local-regional Failure, and QOL Prognostic and Predictive Effects of Gross Tumor Volume on Overall Survival

NCI Description

This dataset will allow users to reproduce the treatment comparison between arms in trial NCT00533949.

Clinical Trial Title

A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer

Trial Summary and Conditions

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy with or without cetuximab in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation therapy given together with chemotherapy with or without cetuximab to see how well they work in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Primary To compare the overall survival of patients with newly diagnosed, unresectable stage IIIA or IIIB non-small cell lung cancer treated with high- versus standard-dose conformal radiotherapy with concurrent and consolidation chemotherapy comprising carboplatin and paclitaxel. To compare the overall survival of patients treated with versus without cetuximab in the setting of concurrent chemotherapy Secondary To compare progression-free survival and local-regional tumor control in patients treated with these regimens. To compare the toxicity of high- versus standard-dose conformal radiotherapy and concurrent chemotherapy with versus without cetuximab in these patients. To investigate the prognostic and predictive effects of gross tumor volume on overall survival of patients treated with these regimens. To compare the quality of life of patients treated with these regimens. To correlate outcomes (i.e., survival, toxicity, or QOL) in these patients with biological parameters. To analyze the predictive value of pre-treatment standardized uptake value (SUV) of positron emission tomography (PET) scan in predicting survival, distant metastasis, and local-regional control in patients treated with these regimens. To explore biological markers to predict clinical outcome including survival, distant metastasis, local-regional control, and QOL (including toxicity) in patients treated with these regimens. To prospectively collect and bank tissue, blood, and urine specimens for future biomarker analyses in predicting clinical outcome in patients treated with these regimens. To investigate associations between epidermal growth factor receptor (EGFR) expression and toxicity, response, overall survival, and progression-free survival.

Outcome Measures

Primary: Overall Survival Secondary: Progression-free Survival Local-regional Failure (Reported as Two-year Estimates) Percentage of Participants With Grade 3-5 Esophagitis and Pneumonitis Adverse Events as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 Percentage of Participants With Other Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0 Death During or Within 30 Days of Discontinuation of Protocol Treatment Percentage of Patients With Decline From Baseline to 3 Months in the Lung Cancer Subscale (LCS) of the Functional Assessment of the Cancer Therapy Trial Outcome Index (FACT-TOI). Patient-reported Swallowing Ability Quality-adjusted Survival Based on EuroQoL (EQ5D)-Derived Health Utility Score Correlation of Tumor Markers With Overall Survival, Local-regional Failure, and QOL Prognostic and Predictive Effects of Gross Tumor Volume on Overall Survival

NCI Description

This dataset will allow users to reproduce the results reported in the New England Journal of Medicine (Moore et al., NEJM, 2015, PMID referenced above) for trial NCT00068601.

Clinical Trial Title

Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer

Trial Summary and Conditions

RATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women receiving chemotherapy for breast cancer. PURPOSE: This randomized phase III trial is studying how well giving goserelin together with chemotherapy works compared with chemotherapy alone in preventing early menopause in women with stage I, stage II, or stage IIIA breast cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Primary Compare the rate of premature ovarian failure in women with stage I-IIIA hormone receptor-negative breast cancer treated with chemotherapy with vs without goserelin. Secondary Compare the rate of ovarian dysfunction in patients treated with these regimens. Compare ovarian reserve in patients treated with these regimens. Describe the pregnancy rates in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are stratified according to age (under 40 vs 40 to 49) and planned chemotherapy regimen (3- to 4-month/course anthracycline-based vs 6- to 8-month/course anthracycline-based vs 3- to 4-month/course non-anthracycline-based vs 6- to 8-month/course non-anthracycline-based). Patients are randomized to 1 of 2 treatment arms. Arm 1: Patients receive cyclophosphamide-containing chemotherapy alone. Patients are followed at 1, 2, and 5 years. Arm 2: Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 416 patients (208 per treatment arm) will be accrued for this study within 3 years.

Outcome Measures

Primary: Rate of Premature Ovarian Failure at 2 Years [ Time Frame: 2 years ] Secondary: Rate of Ovarian Dysfunction at 2 Years [ Time Frame: 2 years ] Rate of Ovarian Dysfunction at 1 Year [ Time Frame: 1 year ]

NCI Description

The dataset will allow users to view descriptions of SUMP75_ANALYSIS file for B-35 primary results paper.

Clinical Trial Title

A Clinical Trial Comparing Anastrozole With Tamoxifen in Postmenopausal Patients With Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy With Radiation Therapy

Trial Summary and Conditions

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Tamoxifen may fight breast cancer by blocking the use of estrogen. Anastrozole may fight breast cancer by decreasing estrogen production. It is not yet known whether anastrozole is more effective than tamoxifen in preventing the recurrence of breast cancer. PURPOSE: This randomized phase III trial is studying anastrozole to see how well it works compared to tamoxifen in preventing the recurrence of breast cancer in postmenopausal women with ductal carcinoma in situ who are undergoing lumpectomy and radiation therapy.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Compare the value of anastrozole vs tamoxifen, in terms of preventing recurrence (i.e., local, regional, and distant recurrences and contralateral breast cancer), after lumpectomy and radiotherapy in postmenopausal women with ductal carcinoma in situ (DCIS). Compare subsequent disease occurrence, in terms of invasive breast cancer (local, regional, distant, or contralateral), ipsilateral and contralateral breast cancer (invasive and DCIS), and non-breast second primary malignancies, in patients treated with these drugs. Compare quality of life and symptoms of patients treated with these drugs. Compare quality-adjusted survival time of patients treated with these drugs. Compare the occurrence of osteoporotic fractures in patients treated with these drugs. Compare disease-free and overall survival of patients treated with these drugs. NOTE: The quality of life study closed to accrual as of 12/28/04. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (under 60 vs 60 and over). Patients are randomized to 1 of 2 treatment arms (arm I and arm II closed to accrual as of 6/15/06). Arm I (closed to accrual as of 6/15/06): Patients receive oral tamoxifen and oral placebo once daily for 5 years. Arm II (closed to accrual as of 6/15/06): Patients receive oral anastrozole and oral placebo once daily for 5 years. Beginning within 8 weeks of randomization, all patients also undergo whole breast radiotherapy, unless the patient is enrolled in protocol NSABP-B-39 and randomized to the partial breast irradiation group. Patients are followed every 6 months for 5 years, and then annually thereafter. For patients enrolled in the quality of life study, quality of life is assessed at baseline and then every 6 months for 6 years. PROJECTED ACCRUAL: A total of 3,000 patients (1,500 per treatment arm) will be accrued for this study within 5 years (arm I and arm II closed to accrual as of 6/15/06).

Outcome Measures

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Tamoxifen may fight breast cancer by blocking the use of estrogen. Anastrozole may fight breast cancer by decreasing estrogen production. It is not yet known whether anastrozole is more effective than tamoxifen in preventing the recurrence of breast cancer. PURPOSE: This randomized phase III trial is studying anastrozole to see how well it works compared to tamoxifen in preventing the recurrence of breast cancer in postmenopausal women with ductal carcinoma in situ who are undergoing lumpectomy and radiation therapy.

NCI Description

This dataset contains data from trial NCT00004054 to reproduce the results in 26209502.

Clinical Trial Title

A Phase III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) vs AS and RT Followed by Chemotherapy With Paclitaxel, Estramustine, and Etoposide (TEE) for Localized, High-Risk, Prostate Cancer

Trial Summary and Conditions

RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus radiation therapy is more effective with or without combination chemotherapy for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Compare the efficacy of androgen suppression and radiotherapy with or without subsequent paclitaxel, estramustine, and etoposide, in terms of overall and disease-free survival, biochemical and local control, and freedom from distant metastasis, in patients with localized high-risk prostate cancer. Compare the toxic effects of these regimens in these patients. OUTLINE: This is a randomized study. Patients are stratified according to prostate-specific antigen level (less than or equal 10 ng/mL vs 11-100 ng/mL), tumor stage (T1-2 vs T3-4), Gleason score (7 vs 8-10), and prior hormone use (yes vs no). Patients are randomized to one of two treatment arms. All patients receive androgen suppression comprising a luteinizing hormone-releasing hormone (LHRH) agonist AND bicalutamide OR flutamide for 4 months. Beginning 8 weeks after the initiation of androgen suppression, all patients undergo radiotherapy once daily, 5 days a week, for 7-8 weeks. Patients who received prior androgen suppression therapy count time to radiotherapy from start date of prior hormonal therapy. Arm I: Patients continue androgen suppression therapy (LHRH agonist only) for approximately 20 more months after radiotherapy is completed. Arm II: Patients continue therapy as in arm I and receive chemotherapy beginning 28 days after completing radiotherapy. Chemotherapy comprises oral estramustine 3 times daily and oral etoposide twice daily on days 1-14 and paclitaxel IV over 1 hour on day 2. Chemotherapy repeats every 21 days for 4 courses. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,440 patients will be accrued for this study within 6 years.

Outcome Measures

Primary: Overall Survival (5-year Rate Reported) [ Time Frame: From the date of randomization to the date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] Secondary: Biochemical Control [ Time Frame: From randomization to the date of prostate-specific antigen (PSA) failure per the American Society for Radiation Oncology (ASTRO) definition or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] Local Progression [ Time Frame: From randomization to the date of local progression or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] Distant Metastasis [ Time Frame: From randomization to the date of metastatic disease or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ]

NCI Description

As of November 6, 2017, there are four different datasets available for NCT00326898. This is NCT00326898-D4. NCT00326898-D1 and NCT00326898-D3 each contain the same clinical data. NCT00326898-D2 and NCT00326898-D4 each contain the same toxicity data. NCT00326898-D1 and NCT00326898-D2 were the original two submissions. NCT00326898-D3 and NCT00326898-D4 updated the original data submissions to include a new blinded ID that will allow for the future linking to non-clinical data (e.g., genomic data). Other than the IDs, the datasets are identical. We recommend that NCT00326898-D3 and NCT00326898-D4 be used.

Clinical Trial Title

ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

Trial Summary and Conditions

This randomized phase III trial studies sunitinib malate and sorafenib tosylate to see how well they work compared to placebo in treating patients with kidney cancer that has been removed by surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib malate or sorafenib tosylate is more effective than placebo in treating kidney cancer.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To demonstrate an improvement in disease-free survival in locally advanced renal cell carcinoma patients randomly assigned to adjuvant sunitinib (sunitinib malate) (Arm A) or sorafenib (sorafenib tosylate) (Arm B) versus placebo (Arm C) after radical or partial nephrectomy. SECONDARY OBJECTIVES: I. To compare overall survival of patients randomized to each of the two regimens with placebo. II. To further define the toxicity of prolonged administration of sunitinib or sorafenib in this patient population. III. To evaluate cardiac function in each arm OTHER PRE-SPECIFIED OBJECTIVES: I. To prospectively collect tumor and biological specimens to assess their characteristics and associations: novel approaches to assess angiogenesis markers in tissue, blood and urine as predictors of disease-free survival and of therapeutic benefit. II. To prospectively collect tumor and biological specimens to assess their characteristics and associations: the frequency of oncogene and tumor suppressor gene mutations as predictors of disease-free survival and therapeutic benefit. III. To prospectively collect tumor and biological specimens to assess their characteristics and associations: tumor and genetic polymorphisms as predictors of disease-free survival and therapeutic benefit. IV. To prospectively collect tumor and biological specimens to assess their characteristics and associations: deoxyribonucleic acid (DNA) methylation profiles as predictors of outcome and of therapeutic benefit. V. To prospectively collect tumor and biological specimens to assess their characteristics and associations: The relationship of polymorphisms in drug metabolizing enzymes with steady state concentrations of sorafenib and sunitinib in selected patients. VI. To study the effect of vascular endothelial growth factor (VEGF) targeted therapy on circulating endothelial cells and circulating endothelial progenitors.

Outcome Measures

Primary: Disease-free Survival (DFS) [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ] Secondary: 5-year Overall Survival Rate [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry ] Proportion of Patients With Cardiac Events [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry ] 5-year Disease-free Survival (DFS) Rate Among Patients With Clear Cell Histology [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ]

NCI Description

As of November 6, 2017, there are four different datasets available for NCT00326898. This is NCT00326898-D3. NCT00326898-D1 and NCT00326898-D3 each contain the same clinical data. NCT00326898-D2 and NCT00326898-D4 each contain the same toxicity data. NCT00326898-D1 and NCT00326898-D2 were the original two submissions. NCT00326898-D3 and NCT00326898-D4 updated the original data submissions to include a new blinded ID that will allow for the future linking to non-clinical data (e.g., genomic data). Other than the IDs, the datasets are identical. We recommend that NCT00326898-D3 and NCT00326898-D4 be used.

Clinical Trial Title

ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

Trial Summary and Conditions

This randomized phase III trial studies sunitinib malate and sorafenib tosylate to see how well they work compared to placebo in treating patients with kidney cancer that has been removed by surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib malate or sorafenib tosylate is more effective than placebo in treating kidney cancer.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To demonstrate an improvement in disease-free survival in locally advanced renal cell carcinoma patients randomly assigned to adjuvant sunitinib (sunitinib malate) (Arm A) or sorafenib (sorafenib tosylate) (Arm B) versus placebo (Arm C) after radical or partial nephrectomy. SECONDARY OBJECTIVES: I. To compare overall survival of patients randomized to each of the two regimens with placebo. II. To further define the toxicity of prolonged administration of sunitinib or sorafenib in this patient population. III. To evaluate cardiac function in each arm OTHER PRE-SPECIFIED OBJECTIVES: I. To prospectively collect tumor and biological specimens to assess their characteristics and associations: novel approaches to assess angiogenesis markers in tissue, blood and urine as predictors of disease-free survival and of therapeutic benefit. II. To prospectively collect tumor and biological specimens to assess their characteristics and associations: the frequency of oncogene and tumor suppressor gene mutations as predictors of disease-free survival and therapeutic benefit. III. To prospectively collect tumor and biological specimens to assess their characteristics and associations: tumor and genetic polymorphisms as predictors of disease-free survival and therapeutic benefit. IV. To prospectively collect tumor and biological specimens to assess their characteristics and associations: deoxyribonucleic acid (DNA) methylation profiles as predictors of outcome and of therapeutic benefit. V. To prospectively collect tumor and biological specimens to assess their characteristics and associations: The relationship of polymorphisms in drug metabolizing enzymes with steady state concentrations of sorafenib and sunitinib in selected patients. VI. To study the effect of vascular endothelial growth factor (VEGF) targeted therapy on circulating endothelial cells and circulating endothelial progenitors.

Outcome Measures

Primary: Disease-free Survival (DFS) [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ] Secondary: 5-year Overall Survival Rate [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry ] Proportion of Patients With Cardiac Events [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry ] 5-year Disease-free Survival (DFS) Rate Among Patients With Clear Cell Histology [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ]"

NCI Description

As of November 6, 2017, there are four different datasets available for NCT00309985. This is NCT00309985-D4. NCT00309985-D1 and NCT00309985-D3 each contain the same clinical data. NCT00309985-D2 and NCT00309985-D4 each contain the same toxicity data. NCT00309985-D1 and NCT00309985-D2 were the original two submissions. NCT00309985-D3 and NCT00309985-D4 updated the original data submissions to include a new blinded ID that will allow for the future linking to non-clinical data (e.g., genomic data). Other than the IDs, the datasets are identical. We recommend that NCT00309985-D3 and NCT00309985-D4 be used.

Clinical Trial Title

CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer

Trial Summary and Conditions

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether androgen-ablation therapy is more effective with or without docetaxel in treating metastatic prostate cancer. PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer.

Data Summary

See data dictionary for more details.

Study Objectives

Primary: Evaluate the ability of early chemotherapy to improve overall survival of patients commencing androgen deprivation for metastatic prostate cancer. Secondary: Determine whether early chemotherapy can increase the time to clinical progression (radiographic or symptomatic deterioration due to disease) over hormonal therapy alone. Determine whether early chemotherapy can increase the time to development of hormone-refractory disease over hormonal therapy alone. Determine whether early chemotherapy can increase the time to serological progression over hormonal therapy alone. Determine rates of biochemical response at 6 months and 12 months in the chemohormonal arm versus the hormonal therapy alone arm. Determine the frequency of adverse events and the tolerability of chemotherapy combined with hormonal therapy versus hormonal therapy alone. Determine whether the postulated clinically meaningful increase in disease control is associated with an alteration in overall quality of life using the Functional Assessment of Cancer Therapy-Prostate questionnaire. Determine the ability of prostate-specific antigen (PSA) changes to be a surrogate for clinical benefit from therapy and overall survival. Tertiary: Determine whether there are proteins differentially translated from the genome in hormone-sensitive prostate cancer, prostate cancer that has responded to hormonal therapy, and hormone-refractory prostate cancer. Determine the frequency of constitutive polymorphisms of enzymes involved in steroid metabolism and other carcinogenic processes. Determine whether the amount and frequency of certain carcinogenic proteins in prostate cancer tissue such as C-X-C chemokine receptor type 4 (CXCR-4) and manganese superoxide dismutase can be correlated with a poor prognosis.

Outcome Measures

Primary: Overall Survival [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ] Secondary: Time to Clinical Progression [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ] Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease) [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ] Proportion of Patients With PSA Complete Response (CR) at 6 Months [ Time Frame: Assessed at 6 months ] Proportion of Patients With PSA Complete Response (CR) at 12 Months [ Time Frame: Assessed at 12 months ] QOL Change From Baseline to 3 Months [ Time Frame: Assessed at baseline and 3 months ]"

NCI Description

As of November 6, 2017, there are four different datasets available for NCT00309985. This is NCT00309985-D3. NCT00309985-D1 and NCT00309985-D3 each contain the same clinical data. NCT00309985-D2 and NCT00309985-D4 each contain the same toxicity data. NCT00309985-D1 and NCT00309985-D2 were the original two submissions. NCT00309985-D3 and NCT00309985-D4 updated the original data submissions to include a new blinded ID that will allow for the future linking to non-clinical data (e.g., genomic data). Other than the IDs, the datasets are identical. We recommend that NCT00309985-D3 and NCT00309985-D4 be used.

Clinical Trial Title

CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer

Trial Summary and Conditions

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether androgen-ablation therapy is more effective with or without docetaxel in treating metastatic prostate cancer. PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer.

Data Summary

See data dictionary for more details.

Study Objectives

Primary: Evaluate the ability of early chemotherapy to improve overall survival of patients commencing androgen deprivation for metastatic prostate cancer. Secondary: Determine whether early chemotherapy can increase the time to clinical progression (radiographic or symptomatic deterioration due to disease) over hormonal therapy alone. Determine whether early chemotherapy can increase the time to development of hormone-refractory disease over hormonal therapy alone. Determine whether early chemotherapy can increase the time to serological progression over hormonal therapy alone. Determine rates of biochemical response at 6 months and 12 months in the chemohormonal arm versus the hormonal therapy alone arm. Determine the frequency of adverse events and the tolerability of chemotherapy combined with hormonal therapy versus hormonal therapy alone. Determine whether the postulated clinically meaningful increase in disease control is associated with an alteration in overall quality of life using the Functional Assessment of Cancer Therapy-Prostate questionnaire. Determine the ability of prostate-specific antigen (PSA) changes to be a surrogate for clinical benefit from therapy and overall survival. Tertiary: Determine whether there are proteins differentially translated from the genome in hormone-sensitive prostate cancer, prostate cancer that has responded to hormonal therapy, and hormone-refractory prostate cancer. Determine the frequency of constitutive polymorphisms of enzymes involved in steroid metabolism and other carcinogenic processes. Determine whether the amount and frequency of certain carcinogenic proteins in prostate cancer tissue such as C-X-C chemokine receptor type 4 (CXCR-4) and manganese superoxide dismutase can be correlated with a poor prognosis.

Outcome Measures

Primary: Overall Survival [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ] Secondary: Time to Clinical Progression [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ] Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease) [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ] Proportion of Patients With PSA Complete Response (CR) at 6 Months [ Time Frame: Assessed at 6 months ] Proportion of Patients With PSA Complete Response (CR) at 12 Months [ Time Frame: Assessed at 12 months ] QOL Change From Baseline to 3 Months [ Time Frame: Assessed at baseline and 3 months ]"

NCI Description

As of November 6, 2017, there are two different datasets available for NCT00049517. This is NCT00049517-D2. NCT00049517-D1 and NCT00049517-D2 each contain the same clinical and mutation data. NCT00049517-D1 was the original submission. NCT00049517-D2 updated the original data submission to include a new blinded ID that will allow for the future linking to non-clinical data (e.g., genomic data). Other than the IDs, the datasets are identical. We recommend that NCT00049517-D2 be used.

Clinical Trial Title

A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation

Trial Summary and Conditions

RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient's stem cells are to be transplanted, the patient is also treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: To compare the overall survival (OS) between two induction regimens (standard versus dose intense daunorubicin and cytarabine) in patients with de novo AML. To compare disease-free survival (DFS) between two consolidation regimens. To compare overall survival between two consolidation regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to induction therapy (standard-dose daunorubicin vs high-dose daunorubicin). Induction therapy: Patients are randomized to 1 of 2 induction arms. Standard: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. High dose: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients in both arms may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. The second course is administered as in arm I to all patients. Patients who don't achieve CR after 2 courses of induction therapy are removed from study. Patients who achieve CR after induction therapy proceed to post-remission therapy with EITHER allogeneic transplantation only (on or off study) OR consolidation therapy and autologous transplantation (on study), according to risk status and donor status. Patients who are considered at intermediate or high risk for relapse (unfavorable cytogenetics/high WBC) and have a suitable related donor undergo an allogeneic transplantation. Patients with intermediate-risk cytogenetics, WBC no greater than 100,000/mm^3, and appropriate donors have the option of undergoing allogeneic transplantation.

Outcome Measures

Primary: Overall Survival (Induction Phase) [ Time Frame: Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter. ] Disease-free Survival (Consolidation Phase) [ Time Frame: Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter. ] Secondary: Overall Survival (Consolidation Phase) [ Time Frame: Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter. ]

NCI Description

This dataset will allow users to reproduce the treatment comparison in trial NCT00002874.

Clinical Trial Title

A PHASE III TRIAL OF RADIATION THERAPY WITH OR WITHOUT CASODEX IN PATIENTS WITH PSA ELEVATION FOLLOWING RADICAL PROSTATECTOMY FOR pT3N0 CARCINOMA OF THE PROSTATE

Trial Summary and Conditions

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.

Data Summary

See data dictionary for more details.

Study Objectives

N/A

Outcome Measures

Primary: Overall Survival (12-year Rates Reported) [ Time Frame: From date of randomization to 12 years. ] Secondary: Non-Prostate Cancer Death (12-year Rates Reported) [ Time Frame: From date of randomization to 12 years. ] Second PSA Recurrence (12-year Rates Reported) [ Time Frame: From date of randomization to 12 years. ] Third PSA Recurrence (12-year Rates Reported) [ Time Frame: From start of salvage hormone therapy to 12 years. ] PSA Complete Response at End of Protocol Treatment [ Time Frame: End of protocol treatment, which is planned to last for two years ] Distant Failure (12-year Rates Reported) [ Time Frame: From date of randomization to 12 years. ] Prostate Cancer Death (12-year Rates Reported) [ Time Frame: From date of randomization to 12 years. ] Progression-free Survival (12-year Rates Reported) [ Time Frame: From date of randomization to 12 years. ] Grade 3+ Toxicity [ Time Frame: From date of randomization to four years. ]

NCI Description

As of 05/25/2018, NCT00003088-D1 is one of 10 datasets associated with PubMed ID 12668651. This dataset, NCT00003088-D1, contains data on complications during treatment by cycle. NCT00003088-D1 and NCT00003088-D6 each contain the same clinical data. NCT00003088-D6 also contains a patient reference (patid) that can be tied to patient information submitted to NCTN Navigator submissions.

Clinical Trial Title

A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at different times or combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: I. Compare the sequential chemotherapy with doxorubicin, paclitaxel and cyclophosphamide to combined doxorubicin and cyclophosphamide followed by paclitaxel for disease free and overall survival in women with node positive stage II or IIIA breast cancer. II. Determine whether increasing the dose density of adjuvant chemotherapy will improve disease free and overall survival. III. Compare the toxicity in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized into one of four arms (sequential chemotherapy every 2 weeks vs every 3 weeks vs concurrent chemotherapy followed by paclitaxel every 2 weeks vs every 3 weeks). All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy plus axillary node dissection. Adjuvant chemotherapy is started within 84 days following the last surgical procedure. See https://clinicaltrials.gov/ct2/show/NCT00003088 for more details.

Outcome Measures

Disease free survival [ Time Frame: 4 years ]

NCI Description

As of 05/25/2018, NCT00003088-D2 is one of 10 datasets associated with PubMed ID 12668651. This dataset, NCT00003088-D2, contains data on complications during treatment by patient. NCT00003088-D2 and NCT00003088-D7 each contain the same clinical data. NCT00003088-D7 also contains a patient reference (patid) that can be tied to patient information submitted to NCTN Navigator submissions.

Clinical Trial Title

A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at different times or combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: I. Compare the sequential chemotherapy with doxorubicin, paclitaxel and cyclophosphamide to combined doxorubicin and cyclophosphamide followed by paclitaxel for disease free and overall survival in women with node positive stage II or IIIA breast cancer. II. Determine whether increasing the dose density of adjuvant chemotherapy will improve disease free and overall survival. III. Compare the toxicity in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized into one of four arms (sequential chemotherapy every 2 weeks vs every 3 weeks vs concurrent chemotherapy followed by paclitaxel every 2 weeks vs every 3 weeks). All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy plus axillary node dissection. Adjuvant chemotherapy is started within 84 days following the last surgical procedure. See https://clinicaltrials.gov/ct2/show/NCT00003088 for more details.

Outcome Measures

Disease free survival [ Time Frame: 4 years ]

NCI Description

As of 05/25/2018, NCT00003088-D3 is one of 10 datasets associated with PubMed ID 12668651. This dataset, NCT00003088-D3, contains data on dose reductions. NCT00003088-D3 and NCT00003088-D8 each contain the same clinical data. NCT00003088-D8 also contains a patient reference (patid) that can be tied to patient information submitted to NCTN Navigator submissions.

Clinical Trial Title

A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at different times or combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: I. Compare the sequential chemotherapy with doxorubicin, paclitaxel and cyclophosphamide to combined doxorubicin and cyclophosphamide followed by paclitaxel for disease free and overall survival in women with node positive stage II or IIIA breast cancer. II. Determine whether increasing the dose density of adjuvant chemotherapy will improve disease free and overall survival. III. Compare the toxicity in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized into one of four arms (sequential chemotherapy every 2 weeks vs every 3 weeks vs concurrent chemotherapy followed by paclitaxel every 2 weeks vs every 3 weeks). All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy plus axillary node dissection. Adjuvant chemotherapy is started within 84 days following the last surgical procedure. See https://clinicaltrials.gov/ct2/show/NCT00003088 for more details.

Outcome Measures

Disease free survival [ Time Frame: 4 years ]

NCI Description

As of 05/25/2018, NCT00003088-D4 is one of 10 datasets associated with PubMed ID 12668651. This dataset, NCT00003088-D4, contains data used to evaluate major toxicities that occurred during protocol treatment. This dataset also contains standard non-hematologic toxicity data for grades 0 to 5 for treated patients. NCT00003088-D4 and NCT00003088-D9 each contain the same clinical data. NCT00003088-D9 also contains a patient reference (patid) that can be tied to patient information submitted to NCTN Navigator submissions.

Clinical Trial Title

A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at different times or combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: I. Compare the sequential chemotherapy with doxorubicin, paclitaxel and cyclophosphamide to combined doxorubicin and cyclophosphamide followed by paclitaxel for disease free and overall survival in women with node positive stage II or IIIA breast cancer. II. Determine whether increasing the dose density of adjuvant chemotherapy will improve disease free and overall survival. III. Compare the toxicity in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized into one of four arms (sequential chemotherapy every 2 weeks vs every 3 weeks vs concurrent chemotherapy followed by paclitaxel every 2 weeks vs every 3 weeks). All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy plus axillary node dissection. Adjuvant chemotherapy is started within 84 days following the last surgical procedure. See https://clinicaltrials.gov/ct2/show/NCT00003088 for more details.

Outcome Measures

Disease free survival [ Time Frame: 4 years ]

NCI Description

As of 05/25/2018, NCT00003088-D5 is one of 10 datasets associated with PubMed ID 12668651. This dataset, NCT00003088-D5, contains one record for treated patients only (N=1973). This dataset also contains the primary and secondary endpoint survival data. NCT00003088-D5 and NCT00003088-D10 each contain the same clinical data. NCT00003088-D10 also contains a patient reference (patid) that can be tied to patient information submitted to NCTN Navigator submissions.

Clinical Trial Title

A Randomized Phase III Trial of Sequential Chemotherapy Using Doxorubicin, Paclitaxel, and Cyclophosphamide or Concurrent Doxorubicin and Cyclophosphamide Followed by Paclitaxel at 14 or 21 Day Intervals in Women With Node Positive Stage II/IIIA Breast Cancer

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at different times or combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy consisting of either doxorubicin, cyclophosphamide, or paclitaxel given at different times with that of combination chemotherapy consisting of doxorubicin plus cyclophosphamide followed by paclitaxel in treating women with stage II or stage IIIA breast cancer.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: I. Compare the sequential chemotherapy with doxorubicin, paclitaxel and cyclophosphamide to combined doxorubicin and cyclophosphamide followed by paclitaxel for disease free and overall survival in women with node positive stage II or IIIA breast cancer. II. Determine whether increasing the dose density of adjuvant chemotherapy will improve disease free and overall survival. III. Compare the toxicity in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized into one of four arms (sequential chemotherapy every 2 weeks vs every 3 weeks vs concurrent chemotherapy followed by paclitaxel every 2 weeks vs every 3 weeks). All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy plus axillary node dissection. Adjuvant chemotherapy is started within 84 days following the last surgical procedure. See https://clinicaltrials.gov/ct2/show/NCT00003088 for more details.

Outcome Measures

Disease free survival [ Time Frame: 4 years ]

NCI Description

As of November 6, 2017, there are four different datasets available for NCT00326898. This is NCT00326898-D2. NCT00326898-D1 and NCT00326898-D3 each contain the same clinical data. NCT00326898-D2 and NCT00326898-D4 each contain the same toxicity data. NCT00326898-D1 and NCT00326898-D2 were the original two submissions. NCT00326898-D3 and NCT00326898-D4 updated the original data submissions to include a new blinded ID that will allow for the future linking to non-clinical data (e.g., genomic data). Other than the IDs, the datasets are identical. We recommend that NCT00326898-D3 and NCT00326898-D4 be used.

Clinical Trial Title

ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

Trial Summary and Conditions

This randomized phase III trial studies sunitinib malate and sorafenib tosylate to see how well they work compared to placebo in treating patients with kidney cancer that has been removed by surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib malate or sorafenib tosylate is more effective than placebo in treating kidney cancer.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To demonstrate an improvement in disease-free survival in locally advanced renal cell carcinoma patients randomly assigned to adjuvant sunitinib (sunitinib malate) (Arm A) or sorafenib (sorafenib tosylate) (Arm B) versus placebo (Arm C) after radical or partial nephrectomy. SECONDARY OBJECTIVES: I. To compare overall survival of patients randomized to each of the two regimens with placebo. II. To further define the toxicity of prolonged administration of sunitinib or sorafenib in this patient population. III. To evaluate cardiac function in each arm OTHER PRE-SPECIFIED OBJECTIVES: I. To prospectively collect tumor and biological specimens to assess their characteristics and associations: novel approaches to assess angiogenesis markers in tissue, blood and urine as predictors of disease-free survival and of therapeutic benefit. II. To prospectively collect tumor and biological specimens to assess their characteristics and associations: the frequency of oncogene and tumor suppressor gene mutations as predictors of disease-free survival and therapeutic benefit. III. To prospectively collect tumor and biological specimens to assess their characteristics and associations: tumor and genetic polymorphisms as predictors of disease-free survival and therapeutic benefit. IV. To prospectively collect tumor and biological specimens to assess their characteristics and associations: deoxyribonucleic acid (DNA) methylation profiles as predictors of outcome and of therapeutic benefit. V. To prospectively collect tumor and biological specimens to assess their characteristics and associations: The relationship of polymorphisms in drug metabolizing enzymes with steady state concentrations of sorafenib and sunitinib in selected patients. VI. To study the effect of vascular endothelial growth factor (VEGF) targeted therapy on circulating endothelial cells and circulating endothelial progenitors.

Outcome Measures

Primary: Disease-free Survival (DFS) [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ] Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation. Secondary: 5-year Overall Survival Rate [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry ] Proportion of Patients With Cardiac Events [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry ] 5-year Disease-free Survival (DFS) Rate Among Patients With Clear Cell Histology [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry ]

NCI Description