Phase II study of TS-1 and CPT-11 combination chemotherapy in patients with advanced/recurrent colorectal cancer.
Phase 2
- Conditions
- advanced/recurrent colorectal cancer
- Registration Number
- JPRN-UMIN000007142
- Lead Sponsor
- Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
Not provided
Exclusion Criteria
1) Interstitial pneumoni, fibroid lung 2) Massive pleural or abdominal effusion 3) Patients with active synchronous or metachronous malignancy other than carcinoma in situ 4) Infection, intestinal paralysis / enterostasis 5) Watery stools or diarrhea 6) Uncontrolled diabetes mellitus 7) Severe complications 8) Metastasis to CNS 9) Pregnant or lactating woman 10) History of the severe hypersensitivity 11) Systemic administration of corticosteroids 12) Other patients who are unfit for the study as determined by the attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method overall survival, frequency and grade of adverse event