NCT00002823

Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,300 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy given after surgery is more effective than surgery alone for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy following surgery with that of surgery alone in treating patients who have stage I, stage II, or stage IIIA non-small cell lung cancer.

Detailed description

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	etoposide
DRUG	vinblastine sulfate
DRUG	vindesine
DRUG	vinorelbine tartrate
RADIATION	radiation therapy

Timeline

• Start date: 1995-02-01
• Primary completion: 2001-01-01
• First posted: 2004-03-11
• Last updated: 2013-03-28

Locations

123 sites across 29 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Czechia, Egypt, Federal Republic of Yugoslavia, France, Greece, Israel, Italy, Japan, Lithuania, Morocco, North Macedonia, Norway, Philippines, Poland, Portugal, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia