{"entity":{"id":"espac-4","kind":"trial","name":"ESPAC-4","aka":["ESPAC4"],"tldr":"ESPAC-4 showed that adding the tablet capecitabine to gemcitabine after pancreatic cancer surgery lengthened median survival from 25.5 to 28 months, and the pair became the adjuvant standard for people who cannot tolerate the harsher FOLFIRINOX regimen.","summary":"ESPAC-4 was an open-label phase 3 trial of the European Study Group for Pancreatic Cancer at 92 hospitals, randomising 730 analysed patients with resected pancreatic ductal adenocarcinoma to six cycles of gemcitabine or gemcitabine with capecitabine. The primary endpoint was overall survival.\n\nMedian overall survival was 28.0 months with the combination against 25.5 months with gemcitabine alone (hazard ratio 0.82), with 608 grade 3 to 4 adverse events in 226 patients on the combination against 481 in 196 patients on gemcitabine. The combination became a standard adjuvant option, later placed behind modified FOLFIRINOX (PRODIGE 24) for fit patients, which is how the corpus's resectable pancreatic cancer page cites it. The trial is registered only with the ISRCTN registry.","status":"positive","asOf":"2026-09-22","links":[{"label":"ISRCTN96397434","url":"https://www.isrctn.com/ISRCTN96397434"}],"tags":["soc-trials"],"related":[],"cancers":["resectable-pdac","pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine","capecitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-espac-4-gemcitabine-capecitabine-adjuvant-neoptolemos-lancet-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN96397434","phase":"3","setting":"Resected pancreatic ductal adenocarcinoma within 12 weeks of surgery in the United Kingdom, Germany, France and Sweden: six cycles of adjuvant gemcitabine alone against gemcitabine plus capecitabine, with overall survival as the primary endpoint","sponsor":"University of Liverpool (Cancer Research UK)","result":"Median overall survival 28.0 months with gemcitabine plus capecitabine against 25.5 months with gemcitabine alone (hazard ratio 0.82, p 0.032).","yearReported":2017,"enrolled":732,"enrolledBasis":"registered","enrolledNote":"ESPAC-4 has no ClinicalTrials.gov record; the figure is the 732 enrolled in the Lancet report, of whom 730 were analysed (366 gemcitabine, 364 gemcitabine plus capecitabine); the trial is registered as ISRCTN96397434.","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Adjuvant gemcitabine + capecitabine","n":364,"value":28,"note":"95% CI 23.5 to 31.5"},{"name":"Adjuvant gemcitabine","n":366,"value":25.5,"note":"95% CI 22.7 to 27.9"}],"hr":0.82,"ci":[0.68,0.98],"p":"0.032","source":"https://doi.org/10.1016/S0140-6736(16)32409-6"},{"endpoint":"Patients with grade 3 to 4 adverse events","unit":"%","arms":[{"name":"Adjuvant gemcitabine + capecitabine","n":359,"value":63,"note":"226 of 359 patients, 608 events"},{"name":"Adjuvant gemcitabine","n":366,"value":54,"note":"196 of 366 patients, 481 events"}],"source":"https://doi.org/10.1016/S0140-6736(16)32409-6"}]},"route":"/trials/espac-4/","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":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"}],"paper":[{"id":"paper-espac-4-gemcitabine-capecitabine-adjuvant-neoptolemos-lancet-2017","kind":"paper","name":"ESPAC-4: adjuvant gemcitabine and capecitabine versus gemcitabine monotherapy in resected pancreatic cancer","route":"/key-papers/paper-espac-4-gemcitabine-capecitabine-adjuvant-neoptolemos-lancet-2017/"}]}}