{"entity":{"id":"jaspac-01","kind":"trial","name":"JASPAC 01","aka":["JASPAC-01","JASPAC01"],"tldr":"JASPAC 01 found that six months of the oral fluoropyrimidine S-1 after pancreatic cancer surgery nearly doubled five-year survival compared with gemcitabine in Japanese patients, 44 against 24 percent, which made S-1 the adjuvant standard in Japan; the result has never been tested in Western patients, who metabolise the drug differently.","summary":"JASPAC 01 randomised 385 patients between April 2007 and June 2010 to gemcitabine (1,000 mg/m2 on days 1, 8 and 15 of a 28-day cycle, up to six cycles) or S-1 (40 to 60 mg twice daily by body surface area for 28 days of a 42-day cycle, up to four cycles). The trial was designed to show non-inferiority (margin 1.25) and was stopped early in September 2012 when the interim analysis met the pre-specified criteria. With follow-up to January 2016 the hazard ratio for death was 0.57 (95 percent confidence interval 0.44 to 0.72; p below 0.0001 for both non-inferiority and superiority), with five-year overall survival 44.1 percent on S-1 against 24.4 percent on gemcitabine. Grade 3 or 4 leucopenia, neutropenia and transaminase rises were commoner with gemcitabine, stomatitis and diarrhoea with S-1. S-1 (tegafur, gimeracil and oteracil) is licensed in Europe as Teysuno for gastric and colorectal cancer only, and the authors asked for the result to be confirmed in non-Asian patients before it is adopted outside Japan; the corpus's adjuvant row cites it as the Japanese standard beside modified FOLFIRINOX and gemcitabine plus capecitabine.","status":"positive","asOf":"2026-09-24","links":[{"label":"Uesaka et al., JASPAC 01 (Lancet 2016)","url":"https://doi.org/10.1016/S0140-6736(16)30583-9"},{"label":"UMIN Clinical Trials Registry UMIN000000655","url":"https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000794"},{"label":"Ueno et al., GEST: S-1 non-inferior to gemcitabine in advanced disease (JCO 2013)","url":"https://doi.org/10.1200/JCO.2012.43.3680"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["tegafur-gimeracil-oteracil","gemcitabine"],"companies":["taiho"],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Resected stage I to III pancreatic ductal adenocarcinoma in Japan, R0 or R1: six cycles of adjuvant gemcitabine against four cycles of oral S-1 for six months, a non-inferiority trial with overall survival as the primary endpoint","sponsor":"Japan Adjuvant Study Group of Pancreatic Cancer (Shizuoka Cancer Center), with Taiho","result":"Five-year overall survival 44.1 percent with adjuvant S-1 against 24.4 percent with gemcitabine (hazard ratio 0.57, 95 percent confidence interval 0.44 to 0.72; p below 0.0001).","yearReported":2016,"enrolled":385,"enrolledBasis":"randomised","enrolledNote":"JASPAC 01 is registered with the UMIN Clinical Trials Registry (UMIN000000655) and has no ClinicalTrials.gov record; 385 patients were randomised at 33 Japanese hospitals and 377 formed the per-protocol population.","outcomes":[{"endpoint":"Overall survival (per-protocol population)","primary":true,"unit":"%","arms":[{"name":"Adjuvant S-1","n":187,"value":44.1,"note":"5-year rate; 95% CI 36.9 to 51.1"},{"name":"Adjuvant gemcitabine","n":190,"value":24.4,"note":"5-year rate; 95% CI 18.6 to 30.8"}],"hr":0.57,"ci":[0.44,0.72],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(16)30583-9"}]},"route":"/trials/jaspac-01/","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":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"tegafur-gimeracil-oteracil","kind":"drug","name":"Tegafur, gimeracil and oteracil (S-1)","route":"/drugs/tegafur-gimeracil-oteracil/"}],"company":[{"id":"taiho","kind":"company","name":"Taiho Pharmaceutical (Otsuka)","route":"/companies/taiho/"}],"term":[{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"}],"trial":[{"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":"prodige-24","kind":"trial","name":"PRODIGE 24 / CCTG PA6","route":"/trials/prodige-24/"}]}}