{"entity":{"id":"prodige-23","kind":"trial","name":"PRODIGE 23","aka":[],"tldr":"PRODIGE 23 showed that six cycles of intensive chemotherapy before chemoradiation improves disease-free survival in rectal cancer and, on longer follow-up, overall survival, the second pillar of total neoadjuvant therapy.","summary":"PRODIGE 23 randomised 461 patients with cT3 or cT4 rectal cancer to standard capecitabine chemoradiation followed by surgery and six months of adjuvant chemotherapy, or to six cycles of induction mFOLFIRINOX before the same sequence. Three-year disease-free survival was 76 percent with induction chemotherapy versus 69 percent (hazard ratio 0.69), pathological complete response rose from 12 to 28 percent (Conroy and colleagues, Lancet Oncology 2021), and seven-year results showed an overall survival gain.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01804790","url":"https://clinicaltrials.gov/study/NCT01804790"},{"label":"Lancet Oncology 2021","url":"https://doi.org/10.1016/S1470-2045(21)00079-6"}],"tags":["radiation-wave4"],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["oxaliplatin","irinotecan","fluorouracil","capecitabine"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":["chemoradiation"],"trials":["stellar-rectal","cao-aro-aio-12","iwwd"],"people":[],"bottlenecks":[],"keyPapers":["paper-conroy-prodige-23-neoadjuvant-folfirinox-rectal-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01804790","phase":"3","setting":"Locally advanced rectal cancer: induction mFOLFIRINOX then chemoradiation, surgery and adjuvant chemotherapy, versus chemoradiation, surgery and adjuvant chemotherapy","sponsor":"UNICANCER","result":"3-year disease-free survival 76% vs 69% (hazard ratio 0.69); pathological complete response 28% vs 12%.","started":"2012-01","startedType":"actual","yearReported":2021,"enrolled":461,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Induction mFOLFIRINOX then chemoradiation","n":231,"value":76},{"name":"Chemoradiation first","n":230,"value":69}]}]},"route":"/trials/prodige-23/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"technology":[{"id":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"irinotecan","kind":"drug","name":"Irinotecan (and liposomal irinotecan)","route":"/drugs/irinotecan/"},{"id":"oxaliplatin","kind":"drug","name":"Oxaliplatin","route":"/drugs/oxaliplatin/"}],"company":[{"id":"unicancer","kind":"company","name":"UNICANCER","route":"/companies/unicancer/"}],"term":[{"id":"chemoradiation","kind":"term","name":"Chemoradiation (chemoradiotherapy, CRT)","route":"/terms/chemoradiation/"}],"trial":[{"id":"cao-aro-aio-12","kind":"trial","name":"CAO/ARO/AIO-12","route":"/trials/cao-aro-aio-12/"},{"id":"cao-aro-aio-94","kind":"trial","name":"CAO/ARO/AIO-94 (German Rectal Cancer Study)","route":"/trials/cao-aro-aio-94/"},{"id":"iwwd","kind":"trial","name":"International Watch & Wait Database","route":"/trials/iwwd/"},{"id":"stellar-rectal","kind":"trial","name":"STELLAR (rectal cancer)","route":"/trials/stellar-rectal/"}],"paper":[{"id":"paper-conroy-prodige-23-neoadjuvant-folfirinox-rectal-lancet-oncol-2021","kind":"paper","name":"Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23)","route":"/key-papers/paper-conroy-prodige-23-neoadjuvant-folfirinox-rectal-lancet-oncol-2021/"}],"roadmap":[{"id":"colorectal-roadmap","kind":"roadmap","name":"Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation","route":"/roadmaps/colorectal-roadmap/"}],"idea":[{"id":"idea-crc-organ-preservation-randomised-in-pmmr-rectal","kind":"idea","name":"Randomise organ preservation against surgery in mismatch repair-proficient rectal cancer, with bowel function as a co-primary endpoint","route":"/ideas/idea-crc-organ-preservation-randomised-in-pmmr-rectal/"}]}}