{"entity":{"id":"prodige-7","kind":"trial","name":"PRODIGE 7","aka":[],"tldr":"Washing the abdomen with heated oxaliplatin after complete tumour removal added nothing to survival and caused more late complications. The surgery, not the wash, is what works.","summary":"PRODIGE 7 randomised 265 patients at 17 French centres who had achieved complete macroscopic resection of colorectal peritoneal metastases to oxaliplatin-based HIPEC (360 mg/m2 closed or 460 mg/m2 open abdomen, with intravenous fluorouracil and folinic acid 20 minutes before) or to no HIPEC. After a median 63.8 months, median overall survival was 41.7 against 41.2 months (hazard ratio 1.00, 95.37% CI 0.63 to 1.58, p=0.99). Grade 3 or worse adverse events at 60 days were more common with HIPEC (26 against 15 percent, p=0.035). Both arms did far better than historical series treated with chemotherapy alone, which is the trial's positive message: complete cytoreductive surgery in selected patients gives a median survival above three years. HIPEC with oxaliplatin does not add to it, and COLOPEC and PROPHYLOCHIP separately showed it does not work as prophylaxis either.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00769405","url":"https://clinicaltrials.gov/study/NCT00769405"},{"label":"PRODIGE 7: cytoreductive surgery plus HIPEC versus cytoreductive surgery alone for colorectal peritoneal metastases (Lancet Oncology 2021)","url":"https://doi.org/10.1016/S1470-2045(20)30599-4"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["hipec","hipec-pipac-devices"],"targets":[],"drugs":["oxaliplatin","fluorouracil","leucovorin"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":["debulking"],"trials":["colopec","prophylochip"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00769405","phase":"3","setting":"Colorectal peritoneal metastases with a Peritoneal Cancer Index of 25 or less, after complete macroscopic cytoreduction: oxaliplatin HIPEC added or not, with systemic chemotherapy in both arms","sponsor":"UNICANCER","result":"Median overall survival 41.7 against 41.2 months (hazard ratio 1.00); more late grade 3 or worse complications with HIPEC.","yearReported":2021,"enrolled":265,"enrolledBasis":"randomised","enrolledNote":"The registry lists 264 participants; 265 were included and randomised in the Lancet Oncology report.","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Cytoreductive surgery plus oxaliplatin HIPEC","n":133,"value":41.7},{"name":"Cytoreductive surgery alone","n":132,"value":41.2}],"hr":1,"ci":[0.63,1.58],"p":"0.99","source":"https://doi.org/10.1016/S1470-2045(20)30599-4"}],"replication":"COLOPEC (adjuvant HIPEC) and PROPHYLOCHIP (second-look surgery plus HIPEC) were also negative, so three randomised trials agree."},"route":"/trials/prodige-7/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"technology":[{"id":"hipec","kind":"technology","name":"HIPEC / PIPAC (intraperitoneal chemotherapy)","route":"/technologies/hipec/"},{"id":"hipec-pipac-devices","kind":"technology","name":"HIPEC perfusion pumps and PIPAC nebulisers","route":"/technologies/hipec-pipac-devices/"}],"drug":[{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"leucovorin","kind":"drug","name":"Leucovorin (folinic acid)","route":"/drugs/leucovorin/"},{"id":"oxaliplatin","kind":"drug","name":"Oxaliplatin","route":"/drugs/oxaliplatin/"}],"company":[{"id":"unicancer","kind":"company","name":"UNICANCER","route":"/companies/unicancer/"}],"term":[{"id":"colorectal-failed-programmes","kind":"term","name":"Colorectal cancer: the failed and stopped programmes, and why","route":"/terms/colorectal-failed-programmes/"},{"id":"debulking","kind":"term","name":"Debulking (cytoreductive surgery)","route":"/terms/debulking/"}],"trial":[{"id":"colopec","kind":"trial","name":"COLOPEC","route":"/trials/colopec/"},{"id":"netherlands-hipec","kind":"trial","name":"Netherlands Cancer Institute HIPEC trial","route":"/trials/netherlands-hipec/"},{"id":"prophylochip","kind":"trial","name":"PROPHYLOCHIP-PRODIGE 15","route":"/trials/prophylochip/"}]}}