Phase II SBRT & Chemo for Unresectable Cholangiocarcinoma Followed by Liver Transplantation
NCT01151761 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2016-07-29
Summary
The purpose of this study is to determine progression-free survival at 12 months for stereotactic body radiotherapy (SBRT) and chemotherapy for unresectable hilar cholangiocarcinoma (CCA).
Conditions
- Cholangiocarcinoma
- Hepatobiliary Neoplasm
- Liver Cancer
- Bile Duct Cancer
- Cancer of Gallbladder
Interventions
- PROCEDURE
-
Stereotactic Body Radiotherapy
Standard of care
- DRUG
-
100 mg/m2, IV
- DRUG
-
25 mg/m2, IV
- DRUG
-
AUC 2, based on Calvert formula, IV
- DRUG
-
1000 mg/m2, PO
- DRUG
-
5FU
200 mg/m2
- PROCEDURE
-
Liver transplantation
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Daniel T Chang · Stanford University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2012-04-30
- Completion
- 2012-07-31
Countries
- United States
Study Locations
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