Squamous Cell Lung Cancer Clinical Trial
Official title:
A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG
Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage I non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether surgery is more effective with or without chemotherapy for non-small cell lung cancer.
PRIMARY OBJECTIVES:
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).
SECONDARY OBJECTIVES:
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
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