Trial Information

A LARGE-SCALE TRIAL EVALUATING ADJUVANT CHEMOTHERAPY AFTER CURATIVE RESECTION OF NON-SMALL CELL LUNG CANCER

OBJECTIVES: I. Compare the impact on overall survival of adjuvant cisplatin and either a
vinca alkaloid or etoposide (with or without radiotherapy) vs. no adjuvant chemotherapy in
patients with completely resected stage I/II/III non-small cell lung cancer. II. Assess the
frequency of treatment-related deaths and severe toxic effects. III. Describe the patterns
of failure, second malignancies, and toxic effects associated with each treatment regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating
institution, type of prior surgery, and pathologic stage. Each participating center will
determine which combination chemotherapy regimen and which of three cisplatin doses will be
given to all patients treated at that center. The treatment group receives cisplatin
combined with either vindesine, vinblastine, vinorelbine, or etoposide every 3-4 weeks for
3-4 courses, depending on the dose of cisplatin. The second group receives no adjuvant
chemotherapy. Treating institutions determine prior to entering the trial which patients
receive adjuvant radiotherapy: none; those with node-positive disease; those with N1 disease
only; those with N2 disease only; or those eligible for a randomized radiotherapy trial. For
patients in the treatment group, radiotherapy begins 3-4 weeks after the last course.
Patients are followed at 6 months, then annually.

PROJECTED ACCRUAL: A maximum of 3,300 patients will be accrued for this study.