{"entity":{"id":"int-0116","kind":"trial","name":"INT-0116 (Macdonald trial)","aka":[],"tldr":"The Macdonald trial made postoperative chemoradiation the US standard for resected stomach cancer in 2001, though later trials with better surgery and chemotherapy have largely replaced it.","summary":"INT-0116 randomised 556 patients after resection of stomach or junctional adenocarcinoma to observation or fluorouracil-leucovorin with 45 Gy radiotherapy. Median overall survival was 36 months with chemoradiation and 27 months with surgery alone (hazard ratio 0.74), and relapse-free survival improved (Macdonald and colleagues, New England Journal of Medicine 2001). Criticism centred on the limited lymph node surgery in most patients; with adequate D2 dissection (ARTIST, CRITICS) the added value of radiotherapy was not confirmed, and perioperative chemotherapy is now the usual approach.","status":"positive","asOf":"2026-09-17","links":[{"label":"NEJM 2001","url":"https://doi.org/10.1056/NEJMoa010187"}],"tags":["radiation-wave4"],"related":[],"cancers":["gastric"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["fluorouracil","leucovorin"],"companies":[],"institutions":[],"pathways":[],"terms":["chemoradiation"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"phase":"3","setting":"Resected gastric or gastro-oesophageal junction adenocarcinoma: postoperative fluorouracil-leucovorin with 45 Gy radiotherapy versus observation","sponsor":"Southwest Oncology Group (US Intergroup)","result":"Median overall survival 36 vs 27 months (hazard ratio 0.74).","yearReported":2001,"enrolled":556,"outcomes":[{"endpoint":"Median overall survival","primary":true,"unit":"months","arms":[{"name":"Chemoradiation","n":281,"value":36},{"name":"Surgery alone","n":275,"value":27}]}]},"route":"/trials/int-0116/","neighbours":{"cancer":[{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"}],"technology":[{"id":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"}],"drug":[{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"leucovorin","kind":"drug","name":"Leucovorin (folinic acid)","route":"/drugs/leucovorin/"}],"term":[{"id":"chemoradiation","kind":"term","name":"Chemoradiation (chemoradiotherapy, CRT)","route":"/terms/chemoradiation/"}]}}