Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer

OBJECTIVES:

Primary

• Compare the survival of patients with resectable non-small cell lung cancer treated with surgery with or without preoperative chemotherapy.

Secondary

• Compare the quality of life of patients treated with these regimens.
• Compare pre-randomization clinical and post-surgical pathological staging in patients treated with these regimens.
• Compare resectability rates in patients treated with these regimens.
• Compare time to and site of relapse in patients treated with these regimens.
• Determine response in patients treated with preoperative chemotherapy.
• Determine the adverse effects of preoperative chemotherapy in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo surgical resection no more than 4 weeks after randomization.
• Arm II: Patients receive one of the following chemotherapy regimens immediately after randomization:

• Regimen 1: Patients receive mitomycin IV, vinblastine IV, and cisplatin IV on day 1.
• Regimen 2: Patients receive mitomycin IV, ifosfamide IV over 3 hours, and cisplatin IV over 1 hour on day 1.
• Regimen 3: Patients receive cisplatin IV over 2 hours on day 1 and vinorelbine IV over 5 -10 minutes on days 1 and 8.
• Regimen 4: Patients receive paclitaxel IV and carboplatin IV on day 1.
• Regimen 5: Patients receive gemcitabine IV on days 1 and 8 and cisplatin IV over 2 hours on day 1.
• Regimen 6: Patients receive docetaxel IV and carboplatin IV on day 1. In all regimens, treatment repeats every 3 weeks for a total of 3 courses. Patients undergo surgical resection at least 4 weeks after the last course of chemotherapy.

Quality of life is assessed at 6 and 12 months and then annually thereafter.

Patients are followed 1 month after surgery, 6 months after randomization, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically proven non-small cell lung cancer

• Resectable disease
• Previously untreated disease
• No evidence of distant metastases

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3,000/mm^3
• Neutrophil count greater than 1,500/mm^3
• Platelet count greater than 100,000/mm^3

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Considered fit for chemotherapy and surgical resection
• No other disease or prior malignancy that would preclude study treatment
• No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent prophylactic colony-stimulating factors (except for secondary prophylaxis)
• No concurrent immunotherapy

Chemotherapy:

• Not specified

Endocrine therapy:

• No concurrent hormonal agents, except corticosteroids

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No other concurrent anticancer therapy