PhaseI/II study of neoadjuvant TS-1+CDDP with concurrent radiation for biliary tract cancer
Phase 1
- Conditions
- Biliary tract cancer
- Registration Number
- JPRN-UMIN000009028
- Lead Sponsor
- Keio University School of Medicine
- 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)bowel movement control is difficult, because of watery diarrhea and chronic diarrhea. (2)administered flucytosine, Phenytoin, Warfarin potassium (3)Pleural effusion or ascitic fluid accumulates (4)with clinically important infection (5)has active carcinoma except carcinoma in situ (6)with gastrointestinal active ulcer (7)sever complication(Heart failure, renal failure,liver failure,Intestinal paralysis,uncontrollable diabetes etc) (8)severe mental disorder (9)pregnant women or during the nursing, women who like be pregnant and willing to get pregnant,men who want his partner to be pregnant (10)doctors decision not to be registered to this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (PhaseI) Estimate the maximum tolerated dose(MTD) and recommended dose(RD) (PhaseII) R0 resection rate
- Secondary Outcome Measures
Name Time Method (PhaseI) Response Rate, Adverse events (PhaseII) Overall survival, 2 year survival rate, Progression Free Survival(PFS), Response Rate(RR), Limited operation rate, adverse events