{"preliminary_commentary":{"by_channel":{"x_thread":4,"podcast":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"name":"OPT-IN","nct_id":"NCT04559139","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=opt-in-nct04559139. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Within 4 weeks of randomization, patients undergo surgery to remove part of the liver, the lymph nodes around the liver, and possibly the bile ducts. Patients then receive gemcitabine IV over 30 minutes and cisplatin IV over 30 minutes-24 hours on days 1 and 8. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.","label":"Arm I (surgery, adjuvant therapy)","type":"ACTIVE_COMPARATOR"},{"description":"Patients receive gemcitabine IV over 30 minutes and cisplatin over 30 minutes-24 hours on days 1 and 8. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Approximately 4-8 weeks after completion of chemotherapy, patients whose disease has not spread to other places in the body (metastasized), then undergo surgery as in Arm I. Patients with successful surgery then resume treatment with gemcitabine IV and cisplatin IV on days 1 and 8. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.","label":"Arm II (neoadjuvant therapy, surgery, adjuvant therapy)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2029-06-30","type":"ESTIMATED"},"conditions":["Stage II Gallbladder Cancer AJCC v8","Stage IIA Gallbladder Cancer AJCC v8","Stage IIB Gallbladder Cancer AJCC v8","Stage III Gallbladder Cancer AJCC v8","Stage IIIA Gallbladder Cancer AJCC v8","Stage IIIB Gallbladder Cancer AJCC v8"],"enrollment":{"count":186,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Cisplatin","otherNames":["Abiplatin","Blastolem","Briplatin","CDDP","Cis-diammine-dichloroplatinum","Cis-diamminedichloridoplatinum","Cis-diamminedichloro Platinum (II)","Cis-diamminedichloroplatinum","Cis-dichloroammine Platinum (II)","Cis-platinous Diamine Dichloride","Cis-platinum","Cis-platinum II","Cis-platinum II Diamine Dichloride","Cismaplat","Cisplatina","Cisplatinum","Cisplatyl","Citoplatino","Citosin","Cysplatyna","DDP","Lederplatin","Metaplatin","Neoplatin","Peyrone''s Chloride","Peyrone''s Salt","Placis","Plastistil","Platamine","Platiblastin","Platiblastin-S","Platinex","Platinol","Platinol- AQ","Platinol-AQ","Platinol-AQ VHA Plus","Platinoxan","Platinum","Platinum Diamminodichloride","Platiran","Platistin","Platosin"],"type":"DRUG"},{"name":"Gemcitabine Hydrochloride","otherNames":["dFdCyd","Difluorodeoxycytidine Hydrochloride","FF 10832","FF-10832","FF10832","Gemcitabine HCI","Gemzar","LY-188011","LY188011"],"type":"DRUG"},{"name":"Lymphadenectomy","otherNames":["excision of the lymph node","Lymph Node Dissection","lymph node excision"],"type":"PROCEDURE"},{"name":"Partial Hepatectomy","otherNames":["partial excision of liver","subtotal hepatectomy"],"type":"PROCEDURE"}],"last_update":"2026-10-19","lead_sponsor":"ECOG-ACRIN Cancer Research Group","official_title":"Optimal Perioperative Therapy for Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2028-07-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Difference in overall survival","timeFrame":"Time from randomization to death or last follow-up, assessed up to 5 years"}],"references":[],"start_date":{"date":"2021-02-24","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Comparison of Chemotherapy Before and After Surgery Versus After Surgery Alone for the Treatment of Gallbladder Cancer","url":"https://clinicaltrials.gov/study/NCT04559139"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/opt-in-nct04559139"}