{"entity":{"id":"prodige-24","kind":"trial","name":"PRODIGE 24 / CCTG PA6","aka":[],"tldr":"Showed that giving the strong four-drug chemotherapy after pancreatic surgery adds years of life for fit patients.","summary":"PRODIGE 24, run with the Canadian Cancer Trials Group as CCTG PA6, trial NCT01526135 and reported in 2018, showed that giving modified FOLFIRINOX after pancreatic cancer surgery adds years of life for fit patients compared with gemcitabine. It randomised 493 patients and met its primary disease-free survival endpoint, and the overall survival benefit held in a five-year update in 2022, establishing modified FOLFIRINOX as the adjuvant standard for patients fit enough to receive it. OnCo links it to pancreatic ductal adenocarcinoma, to the FOLFIRINOX drug record and to Thierry Conroy, and the result is consistent with APACT for gemcitabine and nab-paclitaxel, which showed a smaller effect, and with the neoadjuvant PREOPANC-2 comparison. Whether the same regimen should be given before surgery rather than after is the open question. FOLFIRINOX has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT01526135","url":"https://clinicaltrials.gov/study/NCT01526135"},{"label":"Conroy et al., five-year outcomes of PRODIGE 24/CCTG PA6 (JAMA Oncology 2022)","url":"https://doi.org/10.1001/jamaoncol.2022.3829"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","platinum","topoisomerase-inhibitors"],"targets":[],"drugs":["folfirinox"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":["espac-4","apact","jaspac-01","alliance-a021806","preopanc-3"],"people":["thierry-conroy"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Five-year outcomes (JAMA Oncology 2022, median follow-up 69.7 months, 77 hospitals in France and Canada): median disease-free survival 21.4 against 12.8 months (hazard ratio 0.66; p below 0.001), five-year disease-free survival 26.1 against 19.0 percent; median overall survival 53.5 against 35.5 months (hazard ratio 0.68, 0.54 to 0.85; p 0.001), five-year overall survival 43.2 against 31.4 percent; metastasis-free survival 29.4 against 17.7 months; cancer-specific survival 54.7 against 36.3 months. Grade 3 or 4 adverse events 75.9 against 52.9 percent in the primary report. Eligibility was restricted to fit patients aged 18 to 79 with recovery within 12 weeks of surgery; ESPAC4's long-term analysis found that 26.4 percent of its patients would not have been eligible and that gemcitabine plus capecitabine still helped them (20.7 against 25.9 months). No UK sites."],"nct":"NCT01526135","phase":"3","setting":"Adjuvant therapy after resection of PDAC: mFOLFIRINOX vs gemcitabine","sponsor":"UNICANCER / CCTG","result":"OS 54.4 vs 35.0 months, HR 0.64.","started":"2012-04-16","startedType":"actual","yearReported":2018,"enrolled":493,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival","primary":true,"unit":"months","arms":[{"name":"Adjuvant mFOLFIRINOX","n":247,"value":21.6},{"name":"Adjuvant gemcitabine","n":246,"value":12.8}],"hr":0.58,"ci":[0.46,0.73],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1809775"},{"endpoint":"Overall survival (5-year update)","unit":"months","arms":[{"name":"Adjuvant mFOLFIRINOX","value":53.5},{"name":"Adjuvant gemcitabine","value":35.5}],"hr":0.68,"source":"https://jamanetwork.com/journals/jamaoncology/fullarticle/2795896"}],"replication":"Consistent with APACT (gemcitabine/nab-paclitaxel, smaller effect) and with the neoadjuvant PREOPANC-2 comparison."},"route":"/trials/prodige-24/","neighbours":{"cancer":[{"id":"borderline-resectable-pdac","kind":"cancer","name":"Borderline resectable pancreatic ductal adenocarcinoma","route":"/cancers/borderline-resectable-pdac/"},{"id":"brca-palb2-pdac","kind":"cancer","name":"BRCA or PALB2-mutant pancreatic ductal adenocarcinoma","route":"/cancers/brca-palb2-pdac/"},{"id":"ipmn-cystic-precursors","kind":"cancer","name":"Intraductal papillary mucinous neoplasm and other pancreatic cystic precursors","route":"/cancers/ipmn-cystic-precursors/"},{"id":"msi-high-pdac","kind":"cancer","name":"Mismatch repair deficient (MSI-high) pancreatic ductal adenocarcinoma","route":"/cancers/msi-high-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"resectable-pdac","kind":"cancer","name":"Resectable pancreatic ductal adenocarcinoma","route":"/cancers/resectable-pdac/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"platinum","kind":"technology","name":"Platinum agents","route":"/technologies/platinum/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"drug":[{"id":"folfirinox","kind":"drug","name":"FOLFIRINOX / mFOLFIRINOX","route":"/drugs/folfirinox/"}],"company":[{"id":"unicancer","kind":"company","name":"UNICANCER","route":"/companies/unicancer/"}],"trial":[{"id":"alliance-a021806","kind":"trial","name":"Alliance A021806","route":"/trials/alliance-a021806/"},{"id":"apact","kind":"trial","name":"APACT","route":"/trials/apact/"},{"id":"conko-001","kind":"trial","name":"CONKO-001","route":"/trials/conko-001/"},{"id":"espac-4","kind":"trial","name":"ESPAC-4","route":"/trials/espac-4/"},{"id":"jaspac-01","kind":"trial","name":"JASPAC 01","route":"/trials/jaspac-01/"},{"id":"preopanc-3","kind":"trial","name":"PREOPANC-3","route":"/trials/preopanc-3/"},{"id":"nct07252232","kind":"trial","name":"Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)","route":"/trials/nct07252232/"}],"person":[{"id":"thierry-conroy","kind":"person","name":"Thierry Conroy","route":"/people/thierry-conroy/"}],"term":[{"id":"clinical-benefit-response","kind":"term","name":"Clinical benefit response (the gemcitabine trial endpoint)","route":"/terms/clinical-benefit-response/"},{"id":"neoadjuvant-versus-upfront-surgery-pancreatic","kind":"term","name":"Neoadjuvant therapy versus surgery first for resectable and borderline resectable pancreatic cancer","route":"/terms/neoadjuvant-versus-upfront-surgery-pancreatic/"}],"paper":[{"id":"paper-conroy-folfirinox-pancreatic-nejm-2011","kind":"paper","name":"Conroy 2011: FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer (PRODIGE 4/ACCORD 11)","route":"/key-papers/paper-conroy-folfirinox-pancreatic-nejm-2011/"},{"id":"paper-prodige-24-five-year-outcomes-jama-oncol-2022","kind":"paper","name":"Five-Year Outcomes of FOLFIRINOX vs Gemcitabine as Adjuvant Therapy for Pancreatic Cancer: A Randomized Clinical Trial","route":"/key-papers/paper-prodige-24-five-year-outcomes-jama-oncol-2022/"},{"id":"paper-esmo-pancreatic-cancer-guideline-ann-oncol-2023","kind":"paper","name":"Pancreatic cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up","route":"/key-papers/paper-esmo-pancreatic-cancer-guideline-ann-oncol-2023/"},{"id":"paper-asco-potentially-curable-pancreatic-guideline-update-jco-2019","kind":"paper","name":"Potentially Curable Pancreatic Adenocarcinoma: ASCO Clinical Practice Guideline Update","route":"/key-papers/paper-asco-potentially-curable-pancreatic-guideline-update-jco-2019/"},{"id":"paper-prodige-24-adjuvant-mfolfirinox-pancreatic-nejm-2018","kind":"paper","name":"PRODIGE 24/CCTG PA6: adjuvant modified FOLFIRINOX versus gemcitabine after resection of pancreatic cancer","route":"/key-papers/paper-prodige-24-adjuvant-mfolfirinox-pancreatic-nejm-2018/"}],"roadmap":[{"id":"chemotherapy-roadmap","kind":"roadmap","name":"Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs","route":"/roadmaps/chemotherapy-roadmap/"},{"id":"pancreatic-roadmap","kind":"roadmap","name":"Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question","route":"/roadmaps/pancreatic-roadmap/"}],"idea":[{"id":"idea-pdac-neoadjuvant-chemotherapy-for-all-resectable-disease","kind":"idea","name":"Chemotherapy before surgery for every resectable pancreatic cancer, settled by the two perioperative trials rather than assumed","route":"/ideas/idea-pdac-neoadjuvant-chemotherapy-for-all-resectable-disease/"}]}}