Randomized phase II study of TS-1/CPT-11 versus TS-1/TXL in advanced/recurrent gastric cancer (OGSG 0402)
- Conditions
- advanced/recurrent gastric cancer
- Registration Number
- JPRN-UMIN000000638
- Lead Sponsor
- Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
- Brief Summary
The overall response rate (ORR) was determined by the RECIST criteria as, 33.3% (95% Confidence Interval, CI=20.3-47.9) for S-1 plus irinotecan (n=51) compared to 31.4% (95% CI=19.1-45.9) for S-1 plus paclitaxel (n=51), with no statistically significant difference (p=0.841). PFS was 173 days for S-1 plus irinotecan compared with 141 days for S-1 plus paclitaxel (HR=1.18, p=0.421). The median survival time (MST) was 379 days for S-1 plus irinotecan and 364 days for S-1 plus paclitaxel (HR=0.988, p=0.956) .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 102
Not provided
1) active double cancer 2) with other severe diseases (ileus, interstitial pneumonia/pulmonary fibrosis, cardiac failure, renal dysfunction, liver dysfunction) 3) with infectious diseases 4) under condition of diarrhea 5) with marked chest or abdominal fluid 6) history of allergy against medicine 7) receiving fluoropyrimidine, antifungal flusitosine or Atazanabil sulfate 8) with gastrointestinal bleeding which needs blood transfusion 9) with liver cirrhosis or jaundice 10) with psychiatric disease which needs medicine 11) with cardiac disease which needs therapy 12) with uncontrolled D M 13) with metastasis to the central nerve system 14) under pregnancy or nursing the baby 15) excluded by doctor due to the other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response Rate(RECIS)
- Secondary Outcome Measures
Name Time Method 1.Progression free survival (PFS) 2.Overall survival (OS) 3.Adverse Events