Randomized phase II study comparing Gemcitabine versus TS-1 for advanced bile duct cancer
- Conditions
- Advanced bile duct cancer
- Registration Number
- JPRN-UMIN000001595
- Lead Sponsor
- Osaka International Cancer Institute Department of Hepatobiliary and pancreatic Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 110
Not provided
1.lung fibrosis or intestinal pneumonia 2.Watery diarrhea 3.Severe infection 4.Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc) 5.Medical history of serious allergy reactions to any drug 6.Massive pleural or abdominal effusion 7.Metastasis to central nervous system 8.Active synchronous or metachronous malignancy other than carcinoma in situ 9.Regular use of frucitocin, fenitoin or warfarin 10.Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 11.Severe mental illness 12.Patients who are judged inappropriate for the entry into the study by the investigater
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival(OS)
- Secondary Outcome Measures
Name Time Method Progression free survival(PFS) Adverse events QOL Response rate