This trial is active, not recruiting.

Condition lung cancer
Treatments cisplatin, etoposide, adjuvant therapy
Phase phase 3
Sponsor European Institute of Oncology
Start date January 1994
Trial size 750 participants
Trial identifier NCT00003053, CDR0000065700, CNR-NICO-01, EU-97010


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Eligibility Criteria

Male or female participants up to 70 years old.

DISEASE CHARACTERISTICS: - Histologically proven stage I, II, or IIIA non-small cell lung cancer after radical surgery - No evidence of lymphonodal enlargement during postsurgical chest CT scan PATIENT CHARACTERISTICS: Age: - 70 and under Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Not specified Renal: - Creatinine no greater than 1.5 times the upper limit of normal Pulmonary: - FEV1 at least 1 liter Other: - Less than 10% weight loss in the past 3 months - No prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Radical surgery required

Additional Information

Official title Adjuvant Treatment of Non Small Cell Lung Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).