{"entity":{"id":"petacc-8","kind":"trial","name":"PETACC-8","aka":[],"tldr":"Adding the EGFR antibody cetuximab to chemotherapy after surgery did not help, even in patients whose tumours had no KRAS mutation.","summary":"PETACC-8 randomised 2,559 patients with resected stage III colon cancer in 340 European centres to FOLFOX4 with or without cetuximab. In the 1,602 patients with KRAS exon 2 wild-type tumours, disease-free survival was no different (hazard ratio 1.05, 95% CI 0.85 to 1.29, p=0.66), and there was no benefit in the KRAS exon 2 and BRAF wild-type subgroup either (0.99, 0.76 to 1.28). Grade 3 or 4 acne-like rash affected 27 percent of the cetuximab group. With N0147 reaching the same conclusion in North America, the two trials closed the question: anti-EGFR antibodies work in metastatic left-sided RAS wild-type disease and have no place in the adjuvant setting.","status":"negative","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00265811","url":"https://clinicaltrials.gov/study/NCT00265811"},{"label":"PETACC-8: FOLFOX4 with or without cetuximab in resected stage III colon cancer (Lancet Oncology 2014)","url":"https://doi.org/10.1016/S1470-2045(14)70227-X"}],"tags":[],"related":[],"cancers":["colorectal","colon-cancer"],"sections":[],"technologies":["monoclonal-antibody","cytotoxic-chemotherapy"],"targets":["egfr","kras"],"drugs":["cetuximab","folfox","oxaliplatin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["n0147"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00265811","phase":"3","setting":"Resected stage III colon cancer: FOLFOX4 with or without cetuximab","sponsor":"Fédération Francophone de Cancérologie Digestive","result":"No disease-free survival benefit from cetuximab in KRAS wild-type disease (hazard ratio 1.05).","yearReported":2014,"enrolled":2559,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival (KRAS exon 2 wild-type)","primary":true,"unit":"hazard ratio","arms":[{"name":"FOLFOX4 plus cetuximab","n":791,"value":1.05},{"name":"FOLFOX4","n":811,"value":1}],"hr":1.05,"ci":[0.85,1.29],"p":"0.66","source":"https://doi.org/10.1016/S1470-2045(14)70227-X"}],"replication":"Same result as Alliance N0147 in North America."},"route":"/trials/petacc-8/","neighbours":{"cancer":[{"id":"colon-cancer","kind":"cancer","name":"Colon cancer (adenocarcinoma of the colon)","route":"/cancers/colon-cancer/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"},{"id":"kras","kind":"target","name":"KRAS","route":"/targets/kras/"}],"drug":[{"id":"cetuximab","kind":"drug","name":"Cetuximab","route":"/drugs/cetuximab/"},{"id":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"},{"id":"oxaliplatin","kind":"drug","name":"Oxaliplatin","route":"/drugs/oxaliplatin/"}],"trial":[{"id":"n0147","kind":"trial","name":"Alliance N0147","route":"/trials/n0147/"},{"id":"atomic","kind":"trial","name":"ATOMIC (Alliance A021502)","route":"/trials/atomic/"}],"term":[{"id":"colorectal-failed-programmes","kind":"term","name":"Colorectal cancer: the failed and stopped programmes, and why","route":"/terms/colorectal-failed-programmes/"}]}}