A Phase III Trial of Induction Paclitaxel and Carboplatin Followed By Standard Radiotherapy (64 Gy/7 Weeks) vs. Hyperfractionated Accelerated Radiotherapy (HART 57.6 Gy/2.5 Weeks) For Patients With Unresectable Stage IIIA and IIIB Non-Small Cell Lung Cancer

OBJECTIVES: I. Determine response rates, duration of response, and survival of patients with unresectable or regionally advanced (M0) stage IIIA or IIIB non-small cell lung carcinoma treated with induction paclitaxel and carboplatin followed by conventional vs accelerated radiation. II. Evaluate the patterns of local and distant failure for patients treated with these regimens.

OUTLINE: Patients are stratified by histology (squamous vs nonsquamous), performance status (0 vs 1), disease stage (IIIA vs IIIB), and response to induction chemotherapy (initial response vs no response). All patients receive induction therapy consisting of paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on days 1 and 22. Treatment repeats every 42 days for 2 courses. Patients whose disease has not progressed outside the thorax are then randomized to 1 of 2 treatment arms. Arm I: Patients receive standard radiotherapy once a day, 5 days a week for 6-7 weeks. Arm II: Patients receive hyperfractionated accelerated radiotherapy 3 times daily, 5 days a week over 2.5 weeks. Each fraction is separated by a minimum of 4 hours. Radiotherapy begins between days 43 and 50. Patients are followed at 1 month after radiotherapy, then every 3 months for 2 years, every 6 months for the next 3 years, and annually thereafter.

PROJECTED ACCRUAL: Approximately 294 patients will be accrued for this study within 3.5 years.