Health Condition 1: null- Cholangiocarcinoma
Conditions
Interventions
Intervention1: chemoradiation and chemotherapy: 52.5-60 Gy/ 25 fractions to the gross disease and 45 Gy/ 25 fractions to suspected microscopic disease along with weekly gemcitabine (300 mg/ m2) . In
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival Progression Free SurvivalTimepoint: accrual 5 years followed by follow up of 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Cause Specific Survival CTCAE Toxicity Quality of LifeTimepoint: Accrual 5 years followed by follow up of 3 years | — |
Countries
India
Contacts
Public ContactSupriya Jayant Sastri
Tata Memorial Hospital
Outcome results
None listed