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Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

Unique Dataset IDNCT00379340
SponsorChildren's Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients0RandomizationNoPubMed (PMID)29659330.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeDrug, Procedure, Radiation, BiologicalDataset TypeOther

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 ]

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

Available Downloads:

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00379340-D1-Data-Dictionary_0.pdf

DATA: NCT00379340-D1-Dataset_0.csv