{"preliminary_commentary":{"by_channel":{"x_thread":3},"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,"drugs_tested":null,"indication":"resectable locally advanced rectal cancer","name":"NCT01804790","nct_id":"NCT01804790","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct01804790. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"Néofirinox","arms":[{"description":"Chemoradiotherapy 5 weeks (50 Grays (Gy), 2 Gy/session ; 25 fractions) + capecitabine 800 mg/m² twice daily 5 days/7, excluding weekends), then 6-8 weeks after chemoradiation, surgery with total mesorectal excision (TME), followed by adjuvant chemotherapy for 6 months, either mFolfox6 or capecitabine, depending on the center's choice.","label":"Arm A : Radiotherapy + capecitabine","type":"ACTIVE_COMPARATOR"},{"description":"Drug: Chemotherapy mFolfirinox\n\nInvestigational arm: Neoadjuvant CT mFolfirinox, 6 cycles (ca. 3 months; each cycle = 2 weeks):\n\noxaliplatin: 85 mg/m² in 2 hours at D1 irinotecan: 180 mg/m² in 90 min at D1 folinic acid: 400 mg/m² simultaneously in 2 hours at D1 during the irinotecan infusion 5-fluorouracil (5-FU): 2400 mg/m² continuous infusion during 48 hours (1200 mg/m² at D1 and D2), every 14 days during 2 months (4 cycles).\n\nThen followed by 5 weeks of chemoradiotherapy 50 Gy (2 Gy/session, 5 sessions per week) + capecitabine 800 mg/m² twice daily 5 days/7), then surgery with TME 6-8 weeks after chemoradiation, followed by 3 months of adjuvant chemotherapy, either mFolfox6 or capecitabine depending on the center's choice.","label":"Arm B : Chemotherapy then radiochemotherapy","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2023-07-01","type":"ACTUAL"},"conditions":["Cancer of the Rectum"],"enrollment":{"count":461,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"mFolfirinox","otherNames":[],"type":"DRUG"},{"name":"Radiotherapy 50 Gy","otherNames":[],"type":"RADIATION"},{"name":"Capecitabine","otherNames":[],"type":"DRUG"},{"name":"TME surgery","otherNames":[],"type":"PROCEDURE"},{"name":"mFolfox6 or capecitabine","otherNames":[],"type":"DRUG"}],"last_update":"2025-06-12","lead_sponsor":"UNICANCER","official_title":"Randomized Phase III Study Comparing Preoperative Chemoradiotherapy Alone Versus Neoadjuvant Chemotherapy With Folfirinox Regimen Followed by Preoperative Chemoradiotherapy for Patients With Resectable Locally Advanced Rectal Cancer","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2023-07-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"disease-free survival","timeFrame":"3 years"}],"references":[{"citation":"Conroy T, Bosset JF, Etienne PL, Rio E, Francois E, Mesgouez-Nebout N, Vendrely V, Artignan X, Bouche O, Gargot D, Boige V, Bonichon-Lamichhane N, Louvet C, Morand C, de la Fouchardiere C, Lamfichekh N, Juzyna B, Jouffroy-Zeller C, Rullier E, Marchal F, Gourgou S, Castan F, Borg C; Unicancer Gastrointestinal Group and Partenariat de Recherche en Oncologie Digestive (PRODIGE) Group. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 May;22(5):702-715. doi: 10.1016/S1470-2045(21)00079-6. Epub 2021 Apr 13.","pmid":"33862000","type":"RESULT"}],"start_date":{"date":"2012-01","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer","url":"https://clinicaltrials.gov/study/NCT01804790"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct01804790"}