{"entity":{"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","aka":[],"tldr":"Radiotherapy after gallbladder cancer surgery rests on one 79-patient trial with no comparison arm and a US insurance database. People whose surgery left cancer at the edge or in the nodes are the ones it might help, and they have never been randomised.","summary":"SWOG S0809 gave chemotherapy then chemoradiation to 79 patients after resection with pT2 to 4, node-positive or margin-positive disease: two-year survival was 65 percent and no worse after R1 (60 percent) than R0 (67 percent) resection. Wang's SEER-Medicare nomogram (1,137 patients) predicts benefit for T2 or N1 or worse, and the NCDB validation found radiotherapy associated with lower mortality in T2 to T4 disease. NCCN lists chemoradiation as an option; the UK does not routinely offer it. POLCAGB tests radiotherapy before surgery in locally advanced disease, but the adjuvant R1 or node-positive question, where local recurrence is a real fraction of failures (14 local, 9 combined of 47 relapses in S0809), has no randomised trial.","asOf":"2026-09-24","links":[{"label":"SWOG S0809 (J Clin Oncol 2015)","url":"https://europepmc.org/article/MED/25964250"},{"label":"Wang et al.: nomogram for adjuvant chemoradiotherapy benefit in resected gallbladder cancer (J Clin Oncol 2011)","url":"https://europepmc.org/article/MED/22067404"}],"tags":["gallbladder-evidence"],"related":[],"cancers":["gallbladder"],"sections":[],"technologies":["sbrt"],"targets":[],"drugs":["capecitabine"],"companies":[],"institutions":["swog","tata-memorial"],"pathways":[],"terms":["chemoradiation","radiotherapy","neoadjuvant-adjuvant"],"trials":["swog-s0809","polcagb","bilcap"],"people":[],"bottlenecks":["b-surgery-radiation-innovation","b-trial-enrolment"],"keyPapers":["paper-swog-s0809-adjuvant-chemoradiation-jco-2015","paper-wang-adjuvant-chemoradiotherapy-nomogram-gallbladder-cancer-jco-2011","paper-giannis-ajcc8-gallbladder-staging-validation-cancers-2021"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"After R1 or node-positive resection of gallbladder cancer, capecitabine-based chemoradiation added to adjuvant systemic therapy improves three-year locoregional recurrence-free survival by at least 15 percentage points without reducing overall survival.","rationale":"Local recurrence contributes to about half of relapses after margin-positive resection in the only prospective series; modern conformal radiotherapy has lower toxicity than the regimens of the SEER era.","test":"Randomised phase 2/3 of adjuvant systemic therapy with or without capecitabine-based chemoradiation in R1 or N+ gallbladder cancer, locoregional recurrence-free survival primary in phase 2 and overall survival in phase 3; about 300 patients, feasible only as an international cooperative-group trial.","maturity":"early-clinical","actor":"research","cost":"medium","horizonYears":8},"route":"/ideas/idea-gbc-randomised-adjuvant-chemoradiation-r1-node-positive/","neighbours":{"cancer":[{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"}],"technology":[{"id":"sbrt","kind":"technology","name":"SBRT / SABR (stereotactic radiotherapy)","route":"/technologies/sbrt/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"}],"institution":[{"id":"swog","kind":"institution","name":"SWOG Cancer Research Network","route":"/institutions/swog/"},{"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":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"},{"id":"radiotherapy","kind":"term","name":"Radiotherapy","route":"/terms/radiotherapy/"}],"trial":[{"id":"bilcap","kind":"trial","name":"BILCAP","route":"/trials/bilcap/"},{"id":"polcagb","kind":"trial","name":"POLCAGB","route":"/trials/polcagb/"},{"id":"swog-s0809","kind":"trial","name":"SWOG S0809","route":"/trials/swog-s0809/"}],"bottleneck":[{"id":"b-surgery-radiation-innovation","kind":"bottleneck","name":"Surgery and radiotherapy cure most, get least","route":"/bottlenecks/b-surgery-radiation-innovation/"},{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"}],"paper":[{"id":"paper-wang-adjuvant-chemoradiotherapy-nomogram-gallbladder-cancer-jco-2011","kind":"paper","name":"Nomogram for predicting the benefit of adjuvant chemoradiotherapy for resected gallbladder cancer","route":"/key-papers/paper-wang-adjuvant-chemoradiotherapy-nomogram-gallbladder-cancer-jco-2011/"},{"id":"paper-swog-s0809-adjuvant-chemoradiation-jco-2015","kind":"paper","name":"SWOG S0809: A Phase II Intergroup Trial of Adjuvant Capecitabine and Gemcitabine Followed by Radiotherapy and Concurrent Capecitabine in Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma","route":"/key-papers/paper-swog-s0809-adjuvant-chemoradiation-jco-2015/"},{"id":"paper-giannis-ajcc8-gallbladder-staging-validation-cancers-2021","kind":"paper","name":"Validation of the 8th Edition American Joint Commission on Cancer (AJCC) Gallbladder Cancer Staging System: Prognostic Discrimination and Identification of Key Predictive Factors","route":"/key-papers/paper-giannis-ajcc8-gallbladder-staging-validation-cancers-2021/"}],"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/"}]}}