Last updated: October 20, 2022
Sponsor: Tata Memorial Hospital
Overall Status: Active - Recruiting
Phase
3
Condition
Liver Cancer
Digestive System Neoplasms
Abdominal Cancer
Treatment
N/AClinical Study ID
NCT02773485
TMC IRB 1457
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age >18 years
- Performance Status 0-2
- Tissue diagnosis of adenocarcinoma of the biliary tract. Wherever tissue diagnosis isnot feasible in spite of repeated attempts a multidisciplinary consensus onclinicoradiological diagnosis of cholangiocarcinoma (CA 19-9= 100mg/ml with aradiological evidence of malignant stricture) should be made and patients consentshould be available for treatment without tissue diagnosis.
- Unresectable disease as determined by hepatobiliary surgical team.
- No evidence of peritoneal or distant metastasis.
- No radiological evidence of paraaortic nodal disease.
- Child A or Child B (score 7)
- Ability to tolerate radical treatment.
Exclusion
Exclusion Criteria:
- Multicentric intrahepatic cholangiocarcinoma (however adjacent satellite lesions arepermitted)
- Inability to deliver safe radiation due to high tumor/ liver ratio.
- Active cholangitis.
- Expected Survival<6 months.
- Unresolved biliary tract obstruction.
- Inability in deliver systemic chemotherapy (persistent bilirubin>3)
Study Design
Total Participants: 155
Study Start date:
May 01, 2015
Estimated Completion Date:
June 30, 2025
Study Description
Connect with a study center
Advanced Centre of Treatment Research and Education In Cancer,Tata Memorial Centre
Navi Mumbai, Maharashtra 410210
IndiaActive - Recruiting
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