{"entity":{"id":"norpact-1","kind":"trial","name":"NORPACT-1","aka":["NorPACT-1","Nordic Pancreatic Cancer Trial-1"],"tldr":"NORPACT-1 asked whether giving FOLFIRINOX chemotherapy before surgery helps people whose pancreatic cancer can be removed straight away; it did not, and patients who went straight to surgery were if anything more likely to be alive at 18 months, so upfront surgery remains the standard for clearly resectable disease.","summary":"NORPACT-1 was a Nordic multicentre randomised phase 2 trial in 140 patients with resectable pancreatic head cancer, assigned to four cycles of neoadjuvant FOLFIRINOX then surgery and adjuvant chemotherapy (77) or upfront surgery and adjuvant chemotherapy (63). The primary endpoint was the proportion alive at 18 months by intention to treat.\n\nAt 18 months 60 percent of the neoadjuvant group were alive against 73 percent of the upfront surgery group, and median overall survival was 25.1 against 38.5 months (hazard ratio 1.52); resection rates were similar (82 against 89 percent) and grade 3 or worse adverse events were more frequent with neoadjuvant treatment. With PREOPANC on the other side of the argument, NORPACT-1 is the evidence the corpus's resectable pancreatic cancer page cites against routine neoadjuvant chemotherapy for clearly resectable tumours.","status":"negative","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02919787","url":"https://clinicaltrials.gov/study/NCT02919787"}],"tags":["soc-trials"],"related":[],"cancers":["resectable-pdac","pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["folfirinox","fluorouracil","oxaliplatin","irinotecan"],"companies":[],"institutions":["oslo-radium-hospital","karolinska"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-norpact-1-neoadjuvant-folfirinox-labori-lancet-gastroenterol-hepatol-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02919787","phase":"2","setting":"Resectable pancreatic head cancer in Norway, Sweden, Denmark and Finland: four cycles of neoadjuvant FOLFIRINOX followed by surgery and adjuvant chemotherapy, against upfront surgery and adjuvant chemotherapy, with overall survival at 18 months as the primary endpoint","sponsor":"Oslo University Hospital","result":"Alive at 18 months: 60 percent with neoadjuvant FOLFIRINOX against 73 percent with upfront surgery (p 0.032); median overall survival 25.1 against 38.5 months (hazard ratio 1.52, p 0.050).","yearReported":2024,"enrolled":140,"enrolledBasis":"registry","outcomes":[{"endpoint":"Alive at 18 months (intention to treat)","primary":true,"unit":"%","arms":[{"name":"Neoadjuvant FOLFIRINOX, surgery, adjuvant chemotherapy","n":77,"value":60,"note":"95% CI 49 to 71"},{"name":"Upfront surgery, adjuvant chemotherapy","n":63,"value":73,"note":"95% CI 62 to 84"}],"p":"0.032","source":"https://doi.org/10.1016/S2468-1253(23)00405-3"},{"endpoint":"Overall survival (intention to treat)","unit":"months","arms":[{"name":"Neoadjuvant FOLFIRINOX, surgery, adjuvant chemotherapy","n":77,"value":25.1,"note":"95% CI 17.2 to 34.9"},{"name":"Upfront surgery, adjuvant chemotherapy","n":63,"value":38.5,"note":"95% CI 27.6 to not reached"}],"hr":1.52,"ci":[1,2.33],"p":"0.050","source":"https://doi.org/10.1016/S2468-1253(23)00405-3"},{"endpoint":"Resection rate","unit":"%","arms":[{"name":"Neoadjuvant FOLFIRINOX, surgery, adjuvant chemotherapy","n":77,"value":82},{"name":"Upfront surgery, adjuvant chemotherapy","n":63,"value":89}],"p":"0.24","source":"https://doi.org/10.1016/S2468-1253(23)00405-3"},{"endpoint":"Patients with at least one grade 3 or worse adverse event (safety population)","unit":"%","arms":[{"name":"Neoadjuvant FOLFIRINOX, surgery, adjuvant chemotherapy","n":73,"value":58},{"name":"Upfront surgery, adjuvant chemotherapy","n":47,"value":40}],"source":"https://doi.org/10.1016/S2468-1253(23)00405-3"}]},"route":"/trials/norpact-1/","neighbours":{"cancer":[{"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/"}],"drug":[{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"folfirinox","kind":"drug","name":"FOLFIRINOX / mFOLFIRINOX","route":"/drugs/folfirinox/"},{"id":"irinotecan","kind":"drug","name":"Irinotecan (and liposomal irinotecan)","route":"/drugs/irinotecan/"},{"id":"oxaliplatin","kind":"drug","name":"Oxaliplatin","route":"/drugs/oxaliplatin/"}],"institution":[{"id":"karolinska","kind":"institution","name":"Karolinska University Hospital","route":"/institutions/karolinska/"},{"id":"oslo-radium-hospital","kind":"institution","name":"Oslo University Hospital, The Norwegian Radium Hospital","route":"/institutions/oslo-radium-hospital/"}],"paper":[{"id":"paper-norpact-1-neoadjuvant-folfirinox-labori-lancet-gastroenterol-hepatol-2024","kind":"paper","name":"NORPACT-1: neoadjuvant FOLFIRINOX versus upfront surgery for resectable pancreatic head cancer","route":"/key-papers/paper-norpact-1-neoadjuvant-folfirinox-labori-lancet-gastroenterol-hepatol-2024/"}]}}