NCT00003053

Combination Chemotherapy in Treating Patients With Stage I, II, or IIIA Non-small Cell Lung Cancer That Has Been Surgically Removed

Adjuvant Treatment of Non Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 70 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. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare cisplatin and etoposide with no chemotherapy in treating patients who have stage I, stage II, or stage IIIA non-small cell lung cancer that has been surgically removed.

Detailed description

OBJECTIVES: * Assess the efficacy of the combination of cisplatin and etoposide after radical surgery in prolonging the relapse free and overall survival for stages I, II, and IIIA non-small cell lung cancer. OUTLINE: This a randomized study (treatment vs no treatment). Patients are stratified according to sex and to stage of disease (I vs II vs IIIA). Patient receives cisplatin and etoposide on days 1-3, every 28 days, for 3 cycles. Patient may receive radiation therapy after surgery at the discretion of the physician. PROJECTED ACCRUAL: Approximately 750 patients will be accrued over 3 years.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	etoposide
PROCEDURE	adjuvant therapy

Timeline

• Start date: 1994-01-01
• First posted: 2003-01-27
• Last updated: 2013-09-20

Locations

86 sites across 3 countries: Greece, Italy, South Korea