Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage
- Compare the survival of patients with resectable non-small cell lung cancer treated
with surgery with or without preoperative chemotherapy.
- 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
- Regimen 1: Patients receive mitomycin IV, vinblastine IV, and cisplatin IV on day
- 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
Allocation: Randomized, Primary Purpose: Treatment
Medical Research Council
United States: Federal Government