Last updated on June 2020

Adjuvant Chemoradiation for Patients With High-risk reseCtable Extrahepatic chOlangiocaRcinoma and gallblaDder Cancer

Brief description of study

The study is a multicenter phase II randomized controlled trial. The purpose is to investigate the efficacy and safety of adjuvant chemoradiation for patients with high-risk resectable extrahepatic cholangiocarcinoma and gallbladder cancer.

Detailed Study Description

The trial will recruit 92 patients, and they will be randomized (1:1) into two groups (chemoradiation group, observation group) after operation. Patients in chemoradiation group will receive treatment consisted of one or two cycles of chemotherapy with gemcitabine (1,000 mg/m2 intravenously on days 1 and 8) and capecitabine (1,500 mg/m2 per day on days 1 to 14, in divided doses twice daily) every 21 days. Then patients went on to receive capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week) concurrent with radiotherapy (45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed). Patients in observation group will not receive any anti-cancer therapy.

Clinical Study Identifier: NCT04333927

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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