{"entity":{"id":"correct","kind":"trial","name":"CORRECT","aka":[],"tldr":"The first pill to lengthen life in bowel cancer after everything else has failed. The gain was six weeks and the hand and foot rash was severe in one patient in six.","summary":"CORRECT randomised 760 patients at 114 centres in 16 countries 2:1 to regorafenib or placebo, each with best supportive care, after progression on or within three months of the last standard therapy. Median overall survival was 6.4 against 5.0 months (hazard ratio 0.77, 95% CI 0.64 to 0.94, one-sided p=0.0052) and the primary endpoint was met at a preplanned interim analysis. Treatment-related adverse events affected 93 percent of the regorafenib group; grade 3 or higher hand-foot skin reaction occurred in 17 percent, fatigue in 10 percent, and diarrhoea and hypertension in 7 percent each. The FDA approved regorafenib for colorectal cancer in September 2012 and the EU marketing authorisation for Stivarga followed on 26 August 2013; NICE recommended it in England only in February 2023 (TA866), a decade later.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT01103323","url":"https://clinicaltrials.gov/study/NCT01103323"},{"label":"CORRECT: regorafenib monotherapy for previously treated metastatic colorectal cancer (Lancet 2013)","url":"https://doi.org/10.1016/S0140-6736(12)61900-X"},{"label":"NICE TA866: regorafenib for previously treated metastatic colorectal cancer","url":"https://www.nice.org.uk/guidance/ta866"},{"label":"EMA Stivarga","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/stivarga"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["kinase-inhibitors","antiangiogenic"],"targets":["vegf","braf"],"drugs":["regorafenib"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":["concur"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01103323","phase":"3","setting":"Metastatic colorectal cancer progressing after all approved standard therapies: regorafenib 160 mg daily, three weeks on and one off, with best supportive care, against placebo","sponsor":"Bayer","result":"Median overall survival 6.4 against 5.0 months (hazard ratio 0.77); grade 3 or worse hand-foot skin reaction in 17 percent.","yearReported":2013,"enrolled":760,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Regorafenib plus best supportive care","n":505,"value":6.4},{"name":"Placebo plus best supportive care","n":255,"value":5}],"hr":0.77,"ci":[0.64,0.94],"p":"0.0052 one-sided","source":"https://doi.org/10.1016/S0140-6736(12)61900-X"}],"replication":"CONCUR replicated the survival benefit in Asian patients (8.8 against 6.3 months, hazard ratio 0.55)."},"route":"/trials/correct/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"technology":[{"id":"antiangiogenic","kind":"technology","name":"Anti-angiogenic therapy","route":"/technologies/antiangiogenic/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"braf","kind":"target","name":"BRAF","route":"/targets/braf/"},{"id":"vegf","kind":"target","name":"VEGF / VEGFR","route":"/targets/vegf/"}],"drug":[{"id":"regorafenib","kind":"drug","name":"Regorafenib","route":"/drugs/regorafenib/"}],"company":[{"id":"bayer","kind":"company","name":"Bayer","route":"/companies/bayer/"}],"trial":[{"id":"concur","kind":"trial","name":"CONCUR","route":"/trials/concur/"},{"id":"fresco-2","kind":"trial","name":"FRESCO-2","route":"/trials/fresco-2/"},{"id":"sunlight","kind":"trial","name":"SUNLIGHT","route":"/trials/sunlight/"}]}}