Phase II study of a combination of modified CPT-11 and 5-FU/l-LV (mJIFL) in patients with meatastatic colorectal cancer
- Conditions
- Meatastatic colorectal cancer
- Registration Number
- JPRN-UMIN000000727
- Lead Sponsor
- OGSG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 54
Not provided
1. with interstitial pneumonitis or pulmonary fibrosis 2. cavity fluid which should be taken out 3. with double cancer and/or multiple cancer which excludes carcinoma in situ 4. with infectious disease, intestinal paralysis, or intestinal obstraction 5. under the condition of diarrhea (watery diarrhea) 6. under insulin therapy or uncontrolled DM 7. with ulcer on digestive organs 8. with ischemic cardiac disease 9. with psychological disorder which disturb the entry to the study 10. under HBs-Antigen(+), HCV antibody(+), or HIV antibody(+) 11. under continuous steroids therapy 12. with other severe diseases(cardiac failure, liver dysfunction, or renal dysfunction) 13. brain metastasis with some symptoms 14. pregnant and/or nursing women 15. with allergic history against medicines 16. doctors' stop not to register to the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response Rate
- Secondary Outcome Measures
Name Time Method Time To Progression(TTP), Time To Treatment Failure (TTF), Survival Time, Relative Dose Intensity