Feasibility study of TS-1 adjuvant therapy for resected biliary tract cancer
- Conditions
- Biliary tract cancer
- Registration Number
- JPRN-UMIN000009029
- Lead Sponsor
- Keio University School of Medicin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 50
Not provided
1) with history of TS-1 administration 2)with interstitial pneumonia or pulmonary fibrosis within 28 days before accrual 3)with diarrhea 4)with clinically important infection 5)blood infusion within 14 days before accrual 6)sever complication(Heart failure, renal failure, liver failure, Hemorrhagic peptic ulcer, Intestinal paralysis, Ileus, uncontrollable diabetes mellitus etc) 7)more than moderate degree of Ascitic fluid and Pleural effusion 8)has active carcinoma except carcinoma in situ 9)administered flucytosine, Phenytoin, Warfarin potassium 10) pregnant women or women who like be pregnant and willing to get pregnant, men who want his partner to be pregnant 11) known sever drug allergies 12) sever mental disorder 13) doctor's decision not to be registered to this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment completed rate
- Secondary Outcome Measures
Name Time Method Relative dose intensity Adverse events Disease free survival Overall survival