Chemo Alone or in Combination With Radiation in Unresectable Cholangiocarcinoma

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The study evaluates impact of high dose radiation on overall survival in patients with unresectable nonmetastatic cholangiocarcinoma. The study randomizes patient between systemic chemotherapy alone and systemic chemotherapy and high dose radiation

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tata Memorial Hospital
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• Age >18 years

• Performance Status 0-2

• Tissue diagnosis of adenocarcinoma of the biliary tract. Wherever tissue diagnosis is not feasible in spite of repeated attempts a multidisciplinary consensus on clinicoradiological diagnosis of cholangiocarcinoma (CA 19-9= 100mg/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:

• Multicentric intrahepatic cholangiocarcinoma (however adjacent satellite lesions are permitted)

• 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)