{"entity":{"id":"espac-3","kind":"trial","name":"ESPAC-3","aka":["ESPAC-3 (v2)","ESPAC3"],"tldr":"ESPAC-3 compared the two adjuvant chemotherapies then available after pancreatic cancer surgery and found they gave the same survival, about 23 months, but gemcitabine caused half as many serious side effects; a companion cohort in ampullary and bile duct cancers is still the main randomised evidence for adjuvant chemotherapy in those rarer tumours.","summary":"ESPAC-3 was the European Study Group for Pancreatic Cancer's phase 3 trial at 159 centres in Europe, Australasia, Japan and Canada. After ESPAC-1 established adjuvant chemotherapy, the observation arm was removed and 1,088 patients with resected pancreatic ductal adenocarcinoma were randomised to six months of fluorouracil with folinic acid or gemcitabine. The primary endpoint was overall survival.\n\nMedian survival was 23.0 months with fluorouracil and 23.6 months with gemcitabine (hazard ratio 0.94), with no difference in progression-free survival or quality of life, but treatment-related serious adverse events were twice as common with fluorouracil (14 against 7.5 percent). A periampullary cohort of 428 patients randomised between observation and the two regimens showed a survival benefit for chemotherapy after adjustment for prognostic factors, which is why the corpus's ampullary cancer page cites ESPAC-3 as its adjuvant evidence.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00058201","url":"https://clinicaltrials.gov/study/NCT00058201"}],"tags":["soc-trials"],"related":[],"cancers":["resectable-pdac","pancreatic","ampullary"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil","leucovorin","gemcitabine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-espac-3-fluorouracil-vs-gemcitabine-adjuvant-neoptolemos-jama-2010"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00058201","phase":"3","setting":"Resected pancreatic ductal adenocarcinoma (and a separate periampullary cohort): six months of adjuvant fluorouracil with folinic acid against gemcitabine, with overall survival as the primary endpoint; an observation arm was dropped when ESPAC-1 showed chemotherapy helped","sponsor":"Royal Liverpool University Hospital","result":"Median overall survival 23.0 months with fluorouracil plus folinic acid against 23.6 months with gemcitabine (hazard ratio 0.94, p 0.39); treatment-related serious adverse events 14 against 7.5 percent.","yearReported":2010,"enrolled":1088,"enrolledBasis":"randomised","enrolledNote":"The registry gives an estimated 1,030; the JAMA report randomised 1,088 patients with pancreatic ductal adenocarcinoma (551 to fluorouracil plus folinic acid, 537 to gemcitabine) between 2000 and 2007, and a separate periampullary cohort of 428 was reported in 2012.","outcomes":[{"endpoint":"Overall survival, pancreatic ductal adenocarcinoma cohort","primary":true,"unit":"months","arms":[{"name":"Adjuvant fluorouracil + folinic acid","n":551,"value":23,"note":"95% CI 21.1 to 25.0; median follow-up 34.2 months"},{"name":"Adjuvant gemcitabine","n":537,"value":23.6,"note":"95% CI 21.4 to 26.4"}],"hr":0.94,"ci":[0.81,1.08],"p":"0.39","source":"https://doi.org/10.1001/jama.2010.1275"},{"endpoint":"Patients with treatment-related serious adverse events","unit":"%","arms":[{"name":"Adjuvant fluorouracil + folinic acid","n":551,"value":14},{"name":"Adjuvant gemcitabine","n":537,"value":7.5}],"p":"<0.001","source":"https://doi.org/10.1001/jama.2010.1275"}]},"route":"/trials/espac-3/","neighbours":{"cancer":[{"id":"ampullary","kind":"cancer","name":"Ampullary cancer (ampulla of Vater)","route":"/cancers/ampullary/"},{"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":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"leucovorin","kind":"drug","name":"Leucovorin (folinic acid)","route":"/drugs/leucovorin/"}],"paper":[{"id":"paper-espac-3-fluorouracil-vs-gemcitabine-adjuvant-neoptolemos-jama-2010","kind":"paper","name":"ESPAC-3: adjuvant fluorouracil plus folinic acid versus gemcitabine after pancreatic cancer resection","route":"/key-papers/paper-espac-3-fluorouracil-vs-gemcitabine-adjuvant-neoptolemos-jama-2010/"}]}}