GAIN (AIO/CALGP/ACO)
A German phase 3 of chemotherapy before the second operation for incidental gallbladder cancer that closed in October 2024 with 68 of a planned 333 participants; its report will show how much a small trial can say.
Overview
GAIN, built on the German Registry of Incidental Gallbladder Carcinoma, planned 333 patients randomised to three cycles of gemcitabine and cisplatin before and after radical surgery or to surgery alone with therapy of the investigator's choice; the primary endpoint was overall survival. Recruitment began in August 2019. ClinicalTrials.gov records an actual enrolment of 68 and completion on 10 October 2024, so the trial closed well short of its target and its result will be underpowered.
Notes
top- Key facts: perioperative gemcitabine and cisplatin (three cycles before and after radical resection) versus surgery first, for incidental gallbladder carcinoma after simple cholecystectomy and for resectable cholangiocarcinoma; primary endpoint overall survival; 333 planned, 68 enrolled, completed 10 October 2024 with no stated reason; no results in Europe PMC in September 2026.
- Enrolment: the registry gives 68 actual against 333 planned in the protocol paper; the trial is recorded as completed on 2024-10-10 without a stated reason.
The rationale for OPT-IN and GAIN in one place. Until OPT-IN reports in 2028 the neoadjuvant approach for incidental cancer remains a reasoned choice rather than a proven one.
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.
Similar pages
not linked directly; found by shared links- TrialPOLCAGB
Shares Surgery for gallbladder cancer: simple versus radical cholecystectomy, re-resection and lymphadenectomy, Incidental gallbladder cancer (found after cholecystectomy), Gemcitabine + cisplatin, Neoadjuvant / adjuvant / perioperative and the tag gallbladder-evidence.
- TrialACTICCA-1
Shares Gemcitabine + cisplatin, Neoadjuvant / adjuvant / perioperative, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups) and the tag gallbladder-evidence.
- Key paperSystematic review of management of incidental gallbladder cancer after cholecystectomy
Shares Incidental gallbladder cancer (found after cholecystectomy), Radical (extended) cholecystectomy, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer and the tag gallbladder-evidence.
- Key paperIncidence of finding residual disease for incidental gallbladder carcinoma: implications for re-resection
Shares Incidental gallbladder cancer (found after cholecystectomy), Radical (extended) cholecystectomy, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer and the tag gallbladder-evidence.
- Key paperManagement of incidental gallbladder cancer in the nationwide CAPBIL study
Shares Incidental gallbladder cancer (found after cholecystectomy), Radical (extended) cholecystectomy, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer and the tag gallbladder-evidence.
- Key paperAssociation of Optimal Time Interval to Re-resection for Incidental Gallbladder Cancer With Overall Survival: A Multi-Institution Analysis From the US Extrahepatic Biliary Malignancy Consortium
Shares Incidental gallbladder cancer (found after cholecystectomy), Radical (extended) cholecystectomy, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer and the tag gallbladder-evidence.
- IdeaA national incidental gallbladder cancer pathway: histology for every gallbladder, referral within two weeks, re-resection by eight
Shares OPT-IN (EA2197), Incidental gallbladder cancer (found after cholecystectomy), Radical (extended) cholecystectomy, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials and the tag gallbladder-evidence.
- Key paperOptimal surgical treatment in patients with T1b gallbladder cancer: An international multicenter study
Shares Incidental gallbladder cancer (found after cholecystectomy), Radical (extended) cholecystectomy, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer and the tag gallbladder-evidence.