systemic chemotherapy alone or in combination with high dose chemoradiation for bile duct cancer
- Conditions
- Health Condition 1: null- Cholangiocarcinoma
- Registration Number
- CTRI/2016/08/007156
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 155
ECOG 0 to 2
Tissue diagnosis of adenocarcinoma of the biliary tract Wherever tissue diagnosis is not feasible inspite of repeated attempts a multidisciplinary consensus on clinicoradiological diagnosis of cholangiocarcinoma CA 19.9 100mg per ml with a radiological evidence of malignant stricture should be made and patients consent should 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
Multicentric intrahepatic cholangiocarcinoma however adjacent satellite lesions are permitted
Inability to deliver safe radiation due to high tumor/ liver ratio
Active cholangitis
Expected Survival less than 6 months
Unresolved biliary tract obstruction
Inability in deliver systemic chemotherapy persistent bilirubin more than 3
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival <br/ ><br> Progression Free SurvivalTimepoint: accrual 5 years followed by follow up of 3 years
- Secondary Outcome Measures
Name Time Method Cause Specific Survival <br/ ><br>CTCAE Toxicity <br/ ><br> Quality of LifeTimepoint: Accrual 5 years followed by follow up of 3 years