OPT-IN (EA2197)
A US trial asking whether people whose gallbladder cancer was found by chance should have chemotherapy before their second operation rather than only after it.
Overview
OPT-IN randomises patients with incidentally found T2 to T3 gallbladder cancer to perioperative gemcitabine and cisplatin (before and after radical re-resection) or to re-resection followed by adjuvant chemotherapy. The registry lists an estimated 186 participants, a start date of 24 February 2021, a status of active but not recruiting and an estimated primary completion date of 1 July 2028. It is the first randomised test of the neoadjuvant idea for incidental cancer in a Western population.
Notes
top- Key facts: T2 or T3 gallbladder cancer found incidentally at or after cholecystectomy; neoadjuvant gemcitabine and cisplatin then re-resection (partial hepatectomy with lymphadenectomy) and further chemotherapy versus re-resection then adjuvant chemotherapy; primary endpoint difference in overall survival; 186 planned at 367 US sites; opened February 2021, active but not recruiting, primary completion July 2028. No UK sites.
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.
- Key paperManagement of incidental gallbladder cancer in the nationwide CAPBIL study
Shares A national incidental gallbladder cancer pathway: histology for every gallbladder, referral within two weeks, re-resection by eight, 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 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 A national incidental gallbladder cancer pathway: histology for every gallbladder, referral within two weeks, re-resection by eight, 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 paperRe-resection in Incidental Gallbladder Cancer: Survival and the Incidence of Residual Disease
Shares A national incidental gallbladder cancer pathway: histology for every gallbladder, referral within two weeks, re-resection by eight, 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.
- 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 paperTiming of revision surgery for incidental gallbladder cancer: a systematic review and individual patient data meta-analysis
Shares A national incidental gallbladder cancer pathway: histology for every gallbladder, referral within two weeks, re-resection by eight, 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 paperIncidence of finding residual disease for incidental gallbladder carcinoma: implications for re-resection
Shares Lymphadenectomy (lymph node dissection), 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 paperNeoadjuvant 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
Shares Chemotherapy before the second operation for high-risk incidental gallbladder cancer, GAIN (AIO/CALGP/ACO), Incidental gallbladder cancer (found after cholecystectomy), Neoadjuvant / adjuvant / perioperative and the tag gallbladder-evidence.