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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 CancerUnique Dataset IDnci-data-40ClinicalTrial.gov IDNCT00533949
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.
See data dictionary for more details.
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.
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
Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):
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Data Dictionary: NCT00533949-D3-Data-Dictionary.pdf