{"entity":{"id":"rtog-1016","kind":"trial","name":"RTOG 1016","aka":[],"tldr":"RTOG 1016 tried to spare HPV-positive throat cancer patients the toxicity of cisplatin by using cetuximab instead, and found that survival was worse: cisplatin stays the standard.","summary":"RTOG 1016 randomised 987 patients with HPV-positive oropharyngeal squamous cell carcinoma to accelerated radiotherapy with cisplatin or with cetuximab. Five-year overall survival was 84.6 percent with cisplatin and 77.9 percent with cetuximab, failing non-inferiority, and locoregional failure was higher with cetuximab; overall toxicity was similar (Gillison and colleagues, Lancet 2019). Together with De-ESCALaTE it closed the door on antibody substitution in this good-prognosis disease.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01302834","url":"https://clinicaltrials.gov/study/NCT01302834"},{"label":"Lancet 2019","url":"https://doi.org/10.1016/S0140-6736(18)32779-X"}],"tags":["radiation-wave4"],"related":[],"cancers":["head-and-neck","oropharyngeal-cancer","hpv-positive-oropharyngeal-cancer"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["cisplatin","cetuximab"],"companies":[],"institutions":[],"pathways":[],"terms":["chemoradiation","hpv-testing"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01302834","phase":"3","setting":"HPV-positive oropharyngeal cancer: radiotherapy with cetuximab versus radiotherapy with cisplatin","sponsor":"NRG Oncology","result":"5-year overall survival 84.6% (cisplatin) vs 77.9% (cetuximab); non-inferiority not met.","yearReported":2019,"enrolled":987,"outcomes":[{"endpoint":"Overall survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Radiotherapy plus cisplatin","n":406,"value":84.6},{"name":"Radiotherapy plus cetuximab","n":399,"value":77.9}]}]},"route":"/trials/rtog-1016/","neighbours":{"cancer":[{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"hpv-positive-oropharyngeal-cancer","kind":"cancer","name":"HPV-positive oropharyngeal cancer","route":"/cancers/hpv-positive-oropharyngeal-cancer/"},{"id":"oropharyngeal-cancer","kind":"cancer","name":"Oropharyngeal cancer (tonsil and base of tongue)","route":"/cancers/oropharyngeal-cancer/"}],"technology":[{"id":"hpv-testing","kind":"technology","name":"HPV DNA testing and self-sampling","route":"/technologies/hpv-testing/"},{"id":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"}],"drug":[{"id":"cetuximab","kind":"drug","name":"Cetuximab","route":"/drugs/cetuximab/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"}],"term":[{"id":"chemoradiation","kind":"term","name":"Chemoradiation (chemoradiotherapy, CRT)","route":"/terms/chemoradiation/"}]}}