Adjuvant Treatment of Non Small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 750
- Locations
- 170
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- — to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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:
- •70 and under
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,500/mm3
- •Platelet count at least 100,000/mm3
- •Not specified
- •Creatinine no greater than 1.5 times the upper limit of normal
- •FEV1 at least 1 liter
- •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
- •Radical surgery required
Exclusion Criteria
- Not provided