{"commentary":{"count":7,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":5,"podcast":2},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":false},"name":"ICON8","nct_id":"NCT01654146","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=icon8-nct01654146. The price is fixed at order. We build the report after 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: 1–12 commentary sources"},"registry":{"acronym":"ICON8","arms":[{"description":"Carboplatin and paclitaxel on day 1 of a 21-day cycle for 6 cycles","label":"Arm 1 (Control Arm)","type":"ACTIVE_COMPARATOR"},{"description":"Carboplatin on day 1 and dose-fractionated weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles","label":"Arm 2 (Research arm)","type":"EXPERIMENTAL"},{"description":"Dose-fractionated weekly carboplatin and weekly paclitaxel on day 1, 8 and 15 of a 21-day cycle for 6 cycles.","label":"Arm 3 (Research arm)","type":"EXPERIMENTAL"}],"collaborators":["Cancer Research UK"],"completion_date":null,"conditions":["Ovarian Cancer"],"enrollment":{"count":1485,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Carboplatin","type":"DRUG"},{"name":"Carboplatin","type":"DRUG"},{"name":"Paclitaxel","type":"DRUG"},{"name":"Paclitaxel","type":"DRUG"}],"last_update":"2012-07-31","lead_sponsor":"Medical Research Council","official_title":"An International Phase III Randomised Trial of Dose Fractionated Chemotherapy Compared to Standard Three Weekly Chemotherapy, Following Immediate Primary Surgery or as Part of Delayed Primary Surgery, for Women With Newly Diagnosed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer","overall_status":"UNKNOWN","phases":["PHASE3"],"primary_completion_date":{"date":"2017-06","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Stage 1: Feasibility assessed as the number of cycles and dose intensity of protocol treatment delivered per patient.","timeFrame":"6 months after the 50th patient has been randomised to each arm and 6 months after the 50th patient with a plan to undergo delayed primary surgery has been randomised to each arm"},{"measure":"Stage 1: Safety assessed as the rate of any ≥ grade 3 toxicity experienced per patient.","timeFrame":"6 months after the 50th patient has been randomised to each arm and 6 months after the 50th patient with a plan to undergo delayed primary surgery has been randomised to each arm"},{"measure":"Stage 2: Progression Free Survival rate at 9 months after randomisation","timeFrame":"9 months after first 62 patients randomised per arm"},{"measure":"Stage 3: Progression Free Survival","timeFrame":"PFS expected 1 year after last patient is randomised. OS expected 3 years after last patient is randomised."},{"measure":"Stage 3: Overall Survival","timeFrame":"PFS expected 1 year after last patient is randomised. OS expected 3 years after last patient is randomised."}],"references":[{"citation":"Colomban O, Clamp A, Cook A, McNeish IA, You B. Benefit From Fractionated Dose-Dense Chemotherapy in Patients With Poor Prognostic Ovarian Cancer: ICON-8 Trial. JCO Clin Cancer Inform. 2023 Apr;7:e2200188. doi: 10.1200/CCI.22.00188.","pmid":"37075255","type":"DERIVED"},{"citation":"Clamp AR, James EC, McNeish IA, Dean A, Kim JW, O'Donnell DM, Gallardo-Rincon D, Blagden S, Brenton J, Perren TJ, Sundar S, Lord R, Dark G, Hall M, Banerjee S, Glasspool RM, Hanna CL, Williams S, Scatchard KM, Nam H, Essapen S, Parkinson C, McAvan L, Swart AM, Popoola B, Schiavone F, Badrock J, Fananapazir F, Cook AD, Parmar M, Kaplan R, Ledermann JA. Weekly dose-dense chemotherapy in first-line epithelial ovarian, fallopian tube, or primary peritoneal cancer treatment (ICON8): overall survival results from an open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2022 Jul;23(7):919-930. doi: 10.1016/S1470-2045(22)00283-2. Epub 2022 Jun 9.","pmid":"35690073","type":"DERIVED"},{"citation":"Morgan RD, McNeish IA, Cook AD, James EC, Lord R, Dark G, Glasspool RM, Krell J, Parkinson C, Poole CJ, Hall M, Gallardo-Rincon D, Lockley M, Essapen S, Summers J, Anand A, Zachariah A, Williams S, Jones R, Scatchard K, Walther A, Kim JW, Sundar S, Jayson GC, Ledermann JA, Clamp AR. Objective responses to first-line neoadjuvant carboplatin-paclitaxel regimens for ovarian, fallopian tube, or primary peritoneal carcinoma (ICON8): post-hoc exploratory analysis of a randomised, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):277-288. doi: 10.1016/S1470-2045(20)30591-X. Epub 2020 Dec 22.","pmid":"33357510","type":"DERIVED"},{"citation":"Blagden SP, Cook AD, Poole C, Howells L, McNeish IA, Dean A, Kim JW, O'Donnell DM, Hook J, James EC, White IR, Perren T, Lord R, Dark G, Earl HM, Hall M, Kaplan R, Ledermann JA, Clamp AR. Weekly platinum-based chemotherapy versus 3-weekly platinum-based chemotherapy for newly diagnosed ovarian cancer (ICON8): quality-of-life results of a phase 3, randomised, controlled trial. Lancet Oncol. 2020 Jul;21(7):969-977. doi: 10.1016/S1470-2045(20)30218-7.","pmid":"32615110","type":"DERIVED"}],"start_date":{"date":"2011-06"},"study_type":"INTERVENTIONAL","title":"ICON8: Weekly Chemotherapy in Ovarian Cancer","url":"https://clinicaltrials.gov/study/NCT01654146"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/icon8-nct01654146"}