A Phase I/II Study of Carboplatin and TS-1 in Patients with Advanced Non-small Cell Lung Cancer: CJLSG-0402
Not Applicable
- Conditions
- Advanced non-small cell lung cancer
- Registration Number
- JPRN-C000000234
- Lead Sponsor
- Central Japan Lung Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Not provided
Exclusion Criteria
1. Massive pleural effusion with the incication of local therapy 2. Clinically appearent pericardial effusion 3. Serious medical complications: Uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure. Uncontrolled diabetes mellitus, hypertension, infections. Contraindication for carboplatin or TS-1 use 4. Pulmonary fiblosis detectable on chest X-ray films 5. Pregnant or milk-feeding female. Intention to be pregnant in the future 6. Other clinical difficulites to this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: Safety, maximum tolerated doses, recommended doses Phase II: Response rate
- Secondary Outcome Measures
Name Time Method Phase I: Response rate Phase II: Safety, survival time