S0022:Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage IIIB non-small cell lung cancer.
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Concurrent Cisplatin/Docetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer|
|Study Start Date:||March 2001|
|Study Completion Date:||March 2005|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
Experimental: chemo/RT followed by consolidation chemo
cisplatin docetaxel radiation therapy
|Drug: cisplatin Drug: docetaxel Radiation: radiation therapy|
- Determine survival and time to treatment failure in patients with stage IIIB non-small cell lung cancer treated with induction docetaxel, cisplatin, and radiotherapy followed by consolidation docetaxel.
- Determine the response rate in these patients when treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising docetaxel IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 60 minutes on days 1, 8, 29, and 36. Patients also undergo concurrent radiotherapy daily, 5 days per week, for 6.5 weeks.
At least 1 week and no more than 4 weeks after completion of induction chemoradiotherapy, patients with stable or responding disease receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 30 months.