Feasibility study of perioperative chemotherapy with neoadjuvant GEM+CDDP and adjuvant S-1 for biliary tract cancer
- Conditions
- Biliary tract cancer
- Registration Number
- JPRN-UMIN000021206
- Lead Sponsor
- Keio University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Not provided
1. presence of active double cancer, excluding carcinoma in situ and mucosal carcinoma 2. presence of active infection requiring systemic therapy, excluding viral hepatitis presence of other cancer except carcinoma in situ 3. accumulated pleural effusion or ascites confirmed in chest CT 4. presence of fever more than 38 degrees Celcius at registration 5. women who are pregnant or during the nursing, women who may be pregnant or are willing to get pregnant, or men who are willing to make thier partner pregnant 6. severe mental disorder 7. uncontrollable diabetes mellitus 8. uncontrollable hypertention 9. history of new-onset unstable angina within 3 weeks, progressive angina, or new-onset myocardial infarction within 6 months before registration 10. presence of severe organ dysfunction including postoperative complication (such as heart failure, renal failure, liver failure, and intestinal paralysis) 11. history of severe drug allegy 12. administered flucytosine, phenytoin, or warfarin potassium 13. uncontrollable diarrhea 14. unsuitable candidate to this study judged by a doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method