Phase 2 study of fix dose rate gemcitabine plus S-1 with advanced biliary tract cancer refractory to standard dose rate gemcitabine
- Conditions
- Advanced biliary tract cancer refractory to standard rate gemcitabine
- Registration Number
- JPRN-UMIN000005918
- Lead Sponsor
- Yokohama Clinical Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1) Simultaneous or metachronous (within 3 years) double cancers, with the exception of intramucosal tumor curable with local therapy 2) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 3) Psychosis or severe mental disorder 4) Patients requiring systemic steroids medication 5) Plumonary fibrosis or interstitial pneumonia 6) Uncontrollable watery diarrhea 7) Active bacterial or fungous infection 8) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, uncontrollable diabetes millitus etc 9) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium 10) Patients who can't receive neither iodic drug nor gadolinium because of drug allergy 11) Prior history of chemotherapy with pyrimidine fluoride for the other disease within the 5 years 12) Inadequate physical condition, as diagnosed by primary physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method