{"entity":{"id":"dutch-tme-trial","kind":"trial","name":"Dutch TME trial","aka":["CKVO 95-04"],"tldr":"The trial that proved a week of radiotherapy before rectal cancer surgery halves the chance of the cancer coming back in the pelvis, even when the operation is done properly.","summary":"The Dutch TME trial randomised 1,861 patients with resectable rectal cancer to 5 x 5 Gy preoperative radiotherapy followed by total mesorectal excision, or to total mesorectal excision alone, with surgical quality controlled by training and pathology review. Among the 1,748 who had a macroscopically complete local resection, local recurrence at two years was 2.4 percent with radiotherapy against 8.2 percent without. Two-year overall survival was the same (82.0 against 81.8 percent). The trial settled two questions at once: total mesorectal excision is the operation, and radiotherapy reduces local recurrence without lengthening life, so its use is a trade against long-term bowel and sexual function.","status":"positive","asOf":"2026-09-24","links":[{"label":"Dutch TME trial: preoperative radiotherapy combined with total mesorectal excision (New England Journal of Medicine 2001)","url":"https://doi.org/10.1056/NEJMoa010580"}],"tags":[],"related":[],"cancers":["colorectal","rectal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":["stockholm-iii"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Resectable rectal cancer: short-course preoperative radiotherapy (5 x 5 Gy) plus total mesorectal excision against total mesorectal excision alone","sponsor":"Dutch Colorectal Cancer Group","result":"Local recurrence at two years 2.4 against 8.2 percent; no survival difference.","yearReported":2001,"enrolled":1861,"enrolledBasis":"randomised","enrolledNote":"1,861 patients were randomised and 1,805 were eligible; the trial predates ClinicalTrials.gov.","outcomes":[{"endpoint":"Local recurrence at 2 years","primary":true,"unit":"percent","arms":[{"name":"Radiotherapy plus TME","value":2.4},{"name":"TME alone","value":8.2}],"source":"https://doi.org/10.1056/NEJMoa010580"}]},"route":"/trials/dutch-tme-trial/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"technology":[{"id":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"}],"term":[{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"}],"trial":[{"id":"cao-aro-aio-94","kind":"trial","name":"CAO/ARO/AIO-94 (German Rectal Cancer Study)","route":"/trials/cao-aro-aio-94/"},{"id":"prospect","kind":"trial","name":"PROSPECT (Alliance N1048)","route":"/trials/prospect/"},{"id":"rapido","kind":"trial","name":"RAPIDO","route":"/trials/rapido/"},{"id":"stockholm-iii","kind":"trial","name":"Stockholm III","route":"/trials/stockholm-iii/"},{"id":"swedish-rectal-cancer-trial","kind":"trial","name":"Swedish Rectal Cancer Trial","route":"/trials/swedish-rectal-cancer-trial/"}]}}