Spots Global Cancer Trial Database for Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer

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Trial Identification

Brief Title: Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer

Official Title: A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG

Study ID: NCT00002852

Conditions

Adenocarcinoma of the Lung

Adenosquamous Cell Lung Cancer

Bronchoalveolar Cell Lung Cancer

Large Cell Lung Cancer

Squamous Cell Lung Cancer

Stage IB Non-small Cell Lung Cancer

Interventions

paclitaxel

carboplatin

therapeutic conventional surgery

Study Description

Brief Summary: 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.

Detailed Description: 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.