A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG
I. To determine if adjuvant chemotherapy can favorably alter the prognosis of the subgroup
of resected stage I patients who, following complete surgical resection of their disease,
are defined as "high risk" based on the presence of a T2N0 tumor (according to the criteria
of the International Staging System for lung cancer).
I To compare failure-free survival of patients with T2N0 stage I NSCLC who have and have not
been treated with adjuvant chemotherapy.
II. To determine the toxicities associated with adjuvant chemotherapy. III. To describe the
pattern of disease recurrence.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor
histology (squamous cell vs nonsquamous cell), degree of differentiation (poorly
differentiated vs other), and mediastinal node sampling at surgery (yes vs no). Within 4-8
weeks after surgery, patients are randomized to 1 of 2 treatment arms.
Arm I:Patients receive no further therapy.
Arm II: Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by
carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses.
Patients are followed every 4 months for 2 years and then every 6 months thereafter.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Overall survival (OS)
OS curves will be calculated using the Kaplan-Meier life-table method. Comparison of the survival curve for the two treatment regimens will be performed using the log-rank test for censored data.
Up to 2.4 years
Cancer and Leukemia Group B
United States: Food and Drug Administration
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