{"entity":{"id":"conko-001","kind":"trial","name":"CONKO-001","aka":["CONKO 001","CONKO-1"],"tldr":"CONKO-001 was the trial that made chemotherapy after pancreatic cancer surgery routine: six months of gemcitabine doubled the time before the cancer came back and roughly doubled the share of patients alive at five years, from 10 to 21 percent.","summary":"CONKO-001 was a German and Austrian open-label phase 3 trial that randomised 368 patients with macroscopically complete resection of pancreatic cancer to six cycles of adjuvant gemcitabine or observation between 1998 and 2004. The primary endpoint was disease-free survival.\n\nAt a median follow-up of 136 months, median disease-free survival was 13.4 months with gemcitabine against 6.7 months with observation (hazard ratio 0.55), and overall survival was longer (hazard ratio 0.76), with five-year survival of 20.7 against 10.4 percent and ten-year survival of 12.2 against 7.7 percent. Gemcitabine alone remains the adjuvant option for patients who cannot tolerate combination chemotherapy, which is how the corpus's resectable pancreatic cancer page cites the trial. It is registered only with the ISRCTN registry.","status":"positive","asOf":"2026-09-22","links":[{"label":"ISRCTN34802808","url":"https://www.isrctn.com/ISRCTN34802808"}],"tags":["soc-trials"],"related":[],"cancers":["resectable-pdac","pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["gemcitabine"],"companies":[],"institutions":["charite"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-conko-001-adjuvant-gemcitabine-long-term-oettle-jama-2013"],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN34802808","phase":"3","setting":"Macroscopically complete resection of pancreatic cancer in Germany and Austria: six months of adjuvant gemcitabine against observation, with disease-free survival as the primary endpoint","sponsor":"Charite University, Berlin, Germany","result":"Median disease-free survival 13.4 months with adjuvant gemcitabine against 6.7 months with observation (hazard ratio 0.55); five-year overall survival 20.7 against 10.4 percent (hazard ratio 0.76, p 0.01).","yearReported":2013,"enrolled":368,"enrolledBasis":"randomised","enrolledNote":"CONKO-001 has no ClinicalTrials.gov record; the figure is the 368 randomised in the JAMA report (354 in the intention-to-treat analysis); the trial is registered as ISRCTN34802808.","outcomes":[{"endpoint":"Disease-free survival","primary":true,"unit":"months","arms":[{"name":"Adjuvant gemcitabine","value":13.4,"note":"95% CI 11.6 to 15.3; 354 patients in the intention-to-treat analysis"},{"name":"Observation","value":6.7,"note":"95% CI 6.0 to 7.5"}],"hr":0.55,"ci":[0.44,0.69],"p":"<0.001","source":"https://doi.org/10.1001/jama.2013.279201"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"Adjuvant gemcitabine","value":20.7,"note":"95% CI 14.7 to 26.6"},{"name":"Observation","value":10.4,"note":"95% CI 5.9 to 15.0"}],"hr":0.76,"ci":[0.61,0.95],"p":"0.01","source":"https://doi.org/10.1001/jama.2013.279201"},{"endpoint":"Overall survival at 10 years","unit":"%","arms":[{"name":"Adjuvant gemcitabine","value":12.2,"note":"95% CI 7.3 to 17.2"},{"name":"Observation","value":7.7,"note":"95% CI 3.6 to 11.8"}],"source":"https://doi.org/10.1001/jama.2013.279201"}]},"route":"/trials/conko-001/","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/"}],"institution":[{"id":"charite","kind":"institution","name":"Charité Universitätsmedizin Berlin","route":"/institutions/charite/"}],"paper":[{"id":"paper-conko-001-adjuvant-gemcitabine-long-term-oettle-jama-2013","kind":"paper","name":"CONKO-001: adjuvant gemcitabine and long-term outcomes after resected pancreatic cancer","route":"/key-papers/paper-conko-001-adjuvant-gemcitabine-long-term-oettle-jama-2013/"}]}}