Randomized phase III study of 5-FU continuous infusion (5-FUci) versus CPT-11 plus CDDP (CP) versus S-1 alone (S-1) in advanced gastric cancer (JCOG9912)
Phase 3
- Conditions
- advanced or recurrent gastric cancer
- Registration Number
- JPRN-C000000062
- Lead Sponsor
- Japan Clinical Oncology Group(JCOG)
- Brief Summary
See the datails via "URL releasing results" above. Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 690
Inclusion Criteria
Not provided
Exclusion Criteria
1) patient with marked infection or inflammation 2) patient with severe peritoneal metastasis 3) patient with massive plueral effusion 4) patient with metastasis to CNS 5) patiet with diarrhea 4 or more times per day 6) patient severe medical condition 7) patient with other concurrent malignancy affecting on survival or adverse events 8) pregnant or nursing patient or with intent to bear baby 9) patient evaluated to be inadequate by a attending doctor 10) patient reqiring nutritional support
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival
- Secondary Outcome Measures
Name Time Method time to treatment failure, incidences of adverse events, response rate, non-hospitalized survival