Phase II study of S-1 in patients with gemcitabine-refractory advanced biliary tract cancer
Phase 2
- Conditions
- Patients with gemcitabine-refractory advanced biliary tract cancer
- Registration Number
- JPRN-UMIN000000919
- Lead Sponsor
- ational Cancer Center Hospital East Hepatobiliary and Pancreatic Oncology Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) Regular use of fenitoin, warfarin or frucitocin 2) History of fluorinated pyrimidine use 3) Severe diarrhea 4) Severe mental disorder 5) Severe infection 6) Severe complication 7) Intestinal pneumonia or lung fibrosis 8) History of chest radiotherapy 9) Massive pleural or abdominal effusion 10) Symptomatic brain metastasis 11) History of other active malignancy 12) Pregnancy or the desire to preserve fecundity 13) Inadequate physical condition, as diagnosed by primary physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method Toxicity, progression free survival, Overall survival