A prospective randomized study of adjuvant chemotherapy with navelbine and cisplatin in completely resected non small cell lung cancer
Completed
- Conditions
- on small cell lung cancerCancerNon small cell lung cancer
- Registration Number
- ISRCTN95053737
- Lead Sponsor
- Pierre Fabre Oncologie (France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 840
Inclusion Criteria
1. Histologically proven primary non small cell lung cancer (NSCLC) (except bronchoalveolar carcinoma) stage I (T2N0 only), II, and IIIA according to the 1986 TNM classification
2. Complete resection of the primary tumor (all margins free of disease)
3. Age 18-75 years
4. World Health Organization (WHO) performance status =2
5. Adequate biological functions
Exclusion Criteria
1. Patients with a history of concurrent malignancy (except adequately treated non-melanoma skin cancer or in situ cervical cancer)
2. Previous treatment with adjuvant therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is overall survival, one-sided test, alpha = 0.05, beta = 0.10, delta = 10%, anticipated two-year survival rate is 30%, benefit expected is an absolute improvement of 10% in the two-year survival rate.
- Secondary Outcome Measures
Name Time Method 1. To determine disease-free survival<br>2. To evaluate toxicity related to chemotherapy