{"entity":{"id":"paper-gain-trial-protocol-bmc-cancer-2020","kind":"paper","name":"Neoadjuvant chemotherapy with gemcitabine plus cisplatin followed by radical liver resection versus immediate radical liver resection alone with or without adjuvant chemotherapy in incidentally detected gallbladder carcinoma after simple cholecystectomy or in front of radical resection of BTC (ICC/ECC) - a phase III study of the German registry of incidental gallbladder carcinoma platform (GR)- the AIO/ CALGP/ ACO- GAIN-trial","aka":[],"tldr":"The design of the German GAIN trial: chemotherapy before and after the second operation for gallbladder cancer found by chance, against surgery first.","summary":"Protocol for GAIN, a multicentre randomised open-label phase 3 built on the German Registry of Incidental Gallbladder Carcinoma. Patients with incidentally discovered gallbladder cancer before radical re-resection, or with resectable or borderline resectable cholangiocarcinoma, were to receive three cycles of gemcitabine plus cisplatin before and after surgery, or surgery alone followed by therapy of the investigator's choice. Primary endpoint overall survival; planned 333 patients; recruitment started August 2019. The authors note that gallbladder cancer is suspected before surgery in only about 30 percent of patients and that five-year survival after curative resection is 20 to 40 percent.","asOf":"2026-09-24","links":[{"label":"BMC Cancer 2020","url":"https://doi.org/10.1186/s12885-020-6610-4"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/32059704/"},{"label":"ClinicalTrials.gov NCT03673072","url":"https://clinicaltrials.gov/study/NCT03673072"}],"tags":["gallbladder-evidence"],"related":[],"cancers":["gallbladder","cholangiocarcinoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["krankenhaus-nordwest"],"pathways":[],"terms":["incidental-gallbladder-cancer","neoadjuvant-adjuvant"],"trials":["gain-igbc"],"people":[],"bottlenecks":["b-trial-enrolment"],"keyPapers":[],"journals":["bmc-cancer"],"dependsOn":[],"notes":[],"journal":"BMC Cancer","year":2020,"doi":"10.1186/s12885-020-6610-4","pmid":"32059704","authors":"Goetze TO, Bechstein WO, Bankstahl US, et al.","paperType":"methods","findings":["Planned 333 patients; three cycles of gemcitabine-cisplatin before and after radical surgery vs surgery first; primary endpoint overall survival.","Gallbladder cancer is suspected preoperatively in only about 30 percent of patients (authors' background)."],"whatItMeans":"GAIN closed in October 2024 with 68 participants according to ClinicalTrials.gov, one fifth of its target: the clearest example of how hard it is to run a randomised surgical trial in incidental gallbladder cancer, and why OPT-IN's result matters.","caveats":["Protocol paper; the trial closed far short of its target.","Mixed population of incidental gallbladder cancer and cholangiocarcinoma."],"changedPractice":false,"participants":333},"route":"/key-papers/paper-gain-trial-protocol-bmc-cancer-2020/","neighbours":{"cancer":[{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"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/"}],"institution":[{"id":"krankenhaus-nordwest","kind":"institution","name":"Krankenhaus Nordwest / Institute of Clinical Cancer Research (IKF)","route":"/institutions/krankenhaus-nordwest/"}],"term":[{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"}],"trial":[{"id":"gain-igbc","kind":"trial","name":"GAIN (AIO/CALGP/ACO)","route":"/trials/gain-igbc/"}],"bottleneck":[{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"}],"journal":[{"id":"bmc-cancer","kind":"journal","name":"BMC cancer","route":"/journals/bmc-cancer/"}],"idea":[{"id":"idea-gbc-neoadjuvant-for-high-risk-incidental-cancer","kind":"idea","name":"Chemotherapy before the second operation for high-risk incidental gallbladder cancer","route":"/ideas/idea-gbc-neoadjuvant-for-high-risk-incidental-cancer/"}]}}