Adjuvant Treatment of Non Small Cell Lung Cancer
N/A
70 Years
Both
Lung Cancer
Trial Information
Adjuvant Treatment of Non Small Cell Lung Cancer
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.
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:
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Antonio Nicolucci, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Consorzio Mario Negri Sud
Authority:
United States: Federal Government
Study ID:
CDR0000065700
NCT ID:
NCT00003053
Start Date:
January 1994
Completion Date:
Related Keywords:
- Lung Cancer
- stage I non-small cell lung cancer
- stage II non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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