Status:
TERMINATED
Chemoradiation +Gemcitabine +Continuous 5-FU (Fluorouracil) Followed by High Dose Brachytherapy/Stereotactic Radiation Boost in Locally Advanced Intra/Extrahepatic Cholangiocarcinoma
Lead Sponsor:
University of Utah
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
OBJECTIVES: This study proposes to evaluate the feasibility of delivery of this treatment in terms of toxicity. If toxicity is not acceptable, the treatment is not feasible. Primary Objectives * To ...
Detailed Description
Cholangiocarcinoma is an uncommon tumor arising from the biliary tract. It can be stratified into two categories based on location, intrahepatic and extrahepatic. In the United States, approximately 4...
Eligibility Criteria
Inclusion
- Patients over age 18
- Intra or extrahepatic cholangiocarcinoma confirmed by biopsy/brushings, biliary aneuploidy demonstrated by FISH, or elevated CA 19-9 greater than 100 ng/mL in the presence of a radiographic malignant stricture
- Deemed surgically unresectable by a surgical oncologist
- Malignant disease encompassable within a single radiation field
- ECOG 0-2
- Laboratory values: Hemoglobin ≥ 8.0 (can be transfused to attain this value), Granulocytes \> 1,500, platelets \> 100,000/ul
Exclusion
- Chemotherapy within one month of starting radiation therapy
- Previous abdominal radiotherapy
- Uncontrolled infection or severe active comorbid disease
- Previous malignancy in the past five years, excluding nonmelanoma skin cancers and in situ cervical, bladder or uterine cancer
- Distant metastatic disease (outside regional lymph nodes)
- Pregnancy or lactating women
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00983541
Start Date
September 1 2009
End Date
March 1 2012
Last Update
August 19 2015
Active Locations (1)
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1
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112