Phase II study of second-line chemotherapy using CPT-11 plus CDDP in patients with advanced/recurrent gastric cancer (OGSG 0504)
Not Applicable
- Conditions
- Advanced/Recurrent gastric cancer which has no response to S-1
- Registration Number
- JPRN-UMIN000000693
- Lead Sponsor
- Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
1. with interstitial pneumonitis or pulmonary fibrosis 2. much fluid in the cavity 3. active double cancer except carcinoma in situ or skin cancer 4. with infectious disease which needs treatment 5. intestinal paralysis or ileus 6. watery stool (diarrhea) 7. uncontrolled DM or DM being treated by insulin 8. with ischemic cardiac disease 9. with psycologic disorder which disturbs recruiting to the study 10. with severe diseases (cardiac failure, liver dysfunction or renal dysfunction) 11. pregnant and/or nursing women 12. present and/or past allergy against medicines 13. doctor's decision not to recruit to the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Antitumor response (Response Rate, Duration of response)
- Secondary Outcome Measures
Name Time Method 1) Adverse Events 2) Overall survival 3) Progression free survival;PFS 4) Time to treatment failure;TTF 5) Relative dose intensity