Status:
COMPLETED
Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer
Lead Sponsor:
Yonsei University
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
17-75 years
Phase:
PHASE2
Brief Summary
The study hypothesis is that chemotherapy of irinotecan and gemcitabine will improve local control of cancer and prolong survival in patients with inoperable biliary tract cancer.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed inoperable biliary tract cancer
- Age: 18 \~75 years old
- Performance status: ECOG 0-2
- Hematopoietic:
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hepatic:
- Bilirubin No greater than 2 fold the upper normal limit
- AST/ALT : No greater than 3 fold the upper normal limit
- Renal:
- Creatinine - no greater than 1.5 mg/dL
- Not pregnant
- No other serious medical or psychiatric illness that would preclude giving informed consent or limit
- No prior chemotherapy within 6 months
- No other concurrent anticancer radiotherapy within 6 months
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00832689
Start Date
June 1 2008
End Date
March 1 2010
Last Update
March 28 2011
Active Locations (1)
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1
Severance hospital
Seoul, South Korea, 120750