Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery

OBJECTIVES: I. Compare the effects of concurrent chemoradiotherapy utilizing carboplatin and
paclitaxel with or without prior induction chemotherapy on overall response rate,
disease-free survival, and overall survival in patients with unresectable stage III
non-small cell lung cancer. II. Compare the effects of these treatments on locoregional vs
distant failure in these patients. III. Compare the toxicity of these treatments in these
patients.

OUTLINE: This is a randomized study. Patients are stratified by measurable vs evaluable
disease. Patients are randomized to 1 of 2 treatment arms: Arm I (immediate concurrent
chemoradiotherapy): Patients receive IV paclitaxel over 1 hour followed by IV carboplatin
over 30 minutes on day 1, and radiation therapy to the chest 5 times a week beginning on day
1. Treatment repeats weekly for a total of 7 courses. Arm II (induction chemotherapy
followed by delayed concurrent chemoradiotherapy): Patients receive IV paclitaxel over 3
hours followed by IV carboplatin over 30 minutes; treatment repeats every 3 weeks for 2
courses. Patients then receive 7 courses of concurrent chemoradiotherapy as in Arm I. Total
treatment time is 13 weeks. Patients are followed every 2 months for 2 years, then every 4
months for the next 2 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study within 3 years.

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung
cancer, including: Squamous cell carcinoma Adenocarcinoma (including bronchoalveolar cell)
Large cell anaplastic carcinoma (including giant and clear cell carcinomas) Inoperable or
unresectable stage IIIA or IIIB disease of the following stage groupings: T1 N2 M0 or T2
N2 M0 T3 N2 M0 and T4 N0-2 M0 eligible if staging is based on closeness to the carina or
invasion of the mediastinum or chest wall Patients with contralateral mediastinal disease
(N3) or tumors adjacent to but not invading a vertebral body are eligible if all gross
disease can be encompassed in the study radiation boost field Patients with a transudate,
cytologically negative, nonbloody pleural effusion are eligible if the tumor can be
encompassed within a reasonable field of radiotherapy Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALBG 0-1 Life expectancy:
Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte
count at least 1,500/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 2 times
upper limit of normal Renal: Creatinine clearance at least 20 mL/min Other: Not pregnant
or nursing Effective contraception required of fertile patients No active second
malignancy except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormones
except for steroids administered for adrenal failure or septic shock, or hormones
administered for non-disease-related conditions (e.g., insulin for diabetes)
Glucocorticosteroids permitted as antiemetics Radiotherapy: No prior radiotherapy Surgery:
At least 2 weeks since exploratory thoracotomy