NCT00002852

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
DRUG	paclitaxel	Given IV
DRUG	carboplatin	Given IV
PROCEDURE	therapeutic conventional surgery	Undergo surgery

Timeline

• Start date: 1996-10-01
• Primary completion: 2004-07-01
• First posted: 2003-01-27
• Last updated: 2013-07-03

Locations

1 site across 1 country: United States