Phase I and II study of S-1+vinorelbine in patients with advanced non-small cell cancer
- Conditions
- unresectable non-small cell lung cancer
- Registration Number
- JPRN-UMIN000030999
- Lead Sponsor
- Tottori University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
1. Patient with need of procedure for pleural effusion 2. Patient with need of drainage procedure for cardiac effusion 3. Patient with symptomatic brain metastasis 4. Patient with severe complications 5. Patient with interstitial pneumonia or pulmonary fibrosis diagnosed by chest X-ray 6. Female patient in or having achance or planning of pregnancy or breast feeding 7. Male patient in plannning to impregnate 8. Patient with active multiple cancers 9. Patient with history of drug hypersensitivity 10. Patient with history of hypersensitivity against vinorelbine or other vinca alkaloids 11. Patient with history of hypersensitivity against TS-1 or pyrimidine fluoride 12. Being treated with other pyrimidine fluoride 13. Being treated with flucytosine 14. Any patient judged by the investigator to be unfit to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I study: recommended dose Phase II study: progression free survival
- Secondary Outcome Measures
Name Time Method Disease control rate, Overall survival, Response rate, Safety