Randomized phase III study of gemcitabine plus S-1 combination therapy versus gemcitabine plus cisplatin combination therapy in advanced biliary tract cancer (JCOG1113, FUGA-BT)
Phase 3
- Conditions
- nresectable or recurrent bilary tract cancer
- Registration Number
- JPRN-UMIN000010667
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 350
Inclusion Criteria
Not provided
Exclusion Criteria
1) Synchronous or metachronous (within 5 years) malignancies except carcinoma in situ or intramucosal tumor curatively treated with local therapy 2) Active infection requiring systemic therapy 3) Pregnant or lactating women or women of childbearing potential, Male expecting partner's pregnancy 4) Psychiatric disease 5) Patients requiring systemic steroids medication 6) Interstitial pneumonia, pulmonary fibrosis 7) Serious co-existing illness 8) Unstable angina pectoris within 3 weeks, or with a history of myocardial infarction within 6 months 9) Patients requiring flucytosine, phenytoin or warfarin 10) Impossible to use both iodine and gadolinium due to being allergic to contrast agent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Progression-free survival, Adverse events, Serious adverse events, Clinically-significant adverse events, Response rate, %Planned dose