{"entity":{"id":"polcagb","kind":"trial","name":"POLCAGB","aka":[],"tldr":"In Mumbai, where gallbladder cancer is common, POLCAGB randomised patients with locally advanced but non-metastatic gallbladder cancer to chemotherapy or chemoradiotherapy before surgery. It is the largest randomised trial in gallbladder cancer alone and finished recruiting 124 patients in 2025.","summary":"POLCAGB (NCT02867865) is a randomised trial at Tata Memorial Hospital comparing neoadjuvant chemotherapy with neoadjuvant chemoradiotherapy in biopsy-proven locally advanced gallbladder cancer (T3-4 with predefined clinical and radiological features), excluding resectable and metastatic disease. The protocol planned 314 patients to detect an improvement in median overall survival from 11 to 16.5 months (hazard ratio 0.7) with 80 percent power; the primary endpoint is overall survival, with progression-free survival, R0 resection rate, toxicity, postoperative complications and quality of life as secondary endpoints. The rationale came from a pilot in which neoadjuvant chemoradiation (55 to 57 Gy in 25 fractions with weekly gemcitabine) gave partial or complete response in 77 percent of 26 patients and R0 resection in 46 percent, with biliary leaks in 46 percent linked to the dose to the central hepatobiliary system. The registry lists the trial as phase 2/3, active but no longer recruiting, with 124 patients enrolled and primary completion on 10 September 2025; results were not found in Europe PMC in September 2026. It is the reference trial for chemoradiotherapy as a neoadjuvant strategy in gallbladder cancer.","status":"active","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02867865","url":"https://clinicaltrials.gov/study/NCT02867865"},{"label":"Engineer et al., BMJ Open 2019: POLCAGB protocol","url":"https://doi.org/10.1136/bmjopen-2018-028147"},{"label":"Predictors of toxicity after neoadjuvant chemoradiotherapy for locally advanced gall bladder cancer (Indian J Cancer 2022)","url":"https://doi.org/10.4103/ijc.ijc_822_19"}],"tags":[],"related":[],"cancers":["gallbladder","incidental-gallbladder-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","gallbladder-cancer-surgery"],"targets":[],"drugs":["gemcitabine-cisplatin","gemcitabine","cisplatin"],"companies":[],"institutions":["tata-memorial"],"pathways":[],"terms":["chemoradiation","staging-laparoscopy","neoadjuvant-adjuvant"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-polcagb-protocol-bmj-open-2019"],"journals":[],"dependsOn":[],"notes":["Key facts: biopsy-proven locally advanced (T3 to 4) non-metastatic gallbladder cancer; neoadjuvant gemcitabine-based chemotherapy versus chemoradiotherapy before attempted resection with staging laparoscopy and PET-CT; primary endpoint overall survival, powered for 11 versus 16.5 months (hazard ratio 0.7) with 314 planned; 124 enrolled, active but not recruiting, primary completion 10 September 2025. The pilot that motivated it gave response in 77 percent of 26 patients and R0 resection in 46 percent, with biliary leaks in 46 percent tied to the dose to the central hepatobiliary system.","Enrolment: 124 actual against 314 planned in the protocol paper.","Registered with the Clinical Trials Registry India as CTRI/2016/08/007199; study completion is listed for 10 September 2027."],"nct":"NCT02867865","phase":"2/3","setting":"Locally advanced (T3-4) gallbladder cancer: neoadjuvant gemcitabine-based chemotherapy versus neoadjuvant chemoradiotherapy before attempted resection, with staging laparoscopy and PET-CT","sponsor":"Tata Memorial Hospital","enrolled":124,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/polcagb/","neighbours":{"cancer":[{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"},{"id":"incidental-gallbladder-cancer","kind":"cancer","name":"Incidental gallbladder cancer (found after cholecystectomy)","route":"/cancers/incidental-gallbladder-cancer/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"},{"id":"gallbladder-cancer-surgery","kind":"technology","name":"Surgery for gallbladder cancer: simple versus radical cholecystectomy, re-resection and lymphadenectomy","route":"/technologies/gallbladder-cancer-surgery/"}],"drug":[{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"gemcitabine-cisplatin","kind":"drug","name":"Gemcitabine + cisplatin","route":"/drugs/gemcitabine-cisplatin/"}],"institution":[{"id":"tata-memorial","kind":"institution","name":"Tata Memorial Centre","route":"/institutions/tata-memorial/"}],"term":[{"id":"chemoradiation","kind":"term","name":"Chemoradiation (chemoradiotherapy, CRT)","route":"/terms/chemoradiation/"},{"id":"gallbladder-cancer-in-biliary-trials","kind":"term","name":"Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)","route":"/terms/gallbladder-cancer-in-biliary-trials/"},{"id":"staging-laparoscopy","kind":"term","name":"Laparoscopy (keyhole surgery)","route":"/terms/staging-laparoscopy/"},{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"}],"paper":[{"id":"paper-polcagb-protocol-bmj-open-2019","kind":"paper","name":"A phase III randomised clinical trial of perioperative therapy (neoadjuvant chemotherapy versus chemoradiotherapy) in locally advanced gallbladder cancers (POLCAGB): study protocol","route":"/key-papers/paper-polcagb-protocol-bmj-open-2019/"}],"trial":[{"id":"swog-s0809","kind":"trial","name":"SWOG S0809","route":"/trials/swog-s0809/"}],"roadmap":[{"id":"gallbladder-cancer-roadmap","kind":"roadmap","name":"Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials","route":"/roadmaps/gallbladder-cancer-roadmap/"}],"idea":[{"id":"idea-gbc-randomised-adjuvant-chemoradiation-r1-node-positive","kind":"idea","name":"A randomised trial of adjuvant chemoradiation after margin-positive or node-positive gallbladder cancer resection","route":"/ideas/idea-gbc-randomised-adjuvant-chemoradiation-r1-node-positive/"}]}}