RUGB
RUGB asks whether adding radiotherapy to chemotherapy helps people whose gallbladder cancer cannot be removed but has not spread. It is a 249-patient randomised trial in India, the only phase 2/3 test of radiotherapy in gallbladder cancer alone.
Overview
RUGB (NCT06214572) is an open-label, parallel-arm, integrated phase 2/3 randomised trial at Tata Memorial Centre for histologically proven adenocarcinoma of the gallbladder that is unresectable but non-metastatic, including gallbladder neck primaries with hilar block mimicking hilar cholangiocarcinoma. Patients receive systemic therapy chosen from gemcitabine plus cisplatin, gemcitabine plus oxaliplatin, gemcitabine plus cisplatin plus durvalumab, or gemcitabine plus cisplatin plus nab-paclitaxel, with or without radiotherapy. The primary endpoint is median overall survival; 249 patients are planned, recruitment began in March 2024 and primary completion is listed for July 2029. In the UK the comparable question for locally advanced biliary cancer was addressed by ABC-07, which tested stereotactic radiotherapy after chemotherapy.
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