{"entity":{"id":"de-escalate","kind":"trial","name":"De-ESCALaTE HPV","aka":[],"tldr":"De-ESCALaTE, the European counterpart of RTOG 1016, found that cetuximab gave no less toxicity than cisplatin and worse tumour control in HPV-positive throat cancer.","summary":"De-ESCALaTE randomised 334 patients with low-risk HPV-positive oropharyngeal cancer to 70 Gy radiotherapy with cisplatin or with cetuximab. Severe toxicity, the primary endpoint, did not differ, while two-year overall survival was 97.5 percent with cisplatin and 89.4 percent with cetuximab and recurrence was more frequent with cetuximab (Mehanna and colleagues, Lancet 2019).","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01874171","url":"https://clinicaltrials.gov/study/NCT01874171"},{"label":"Lancet 2019","url":"https://doi.org/10.1016/S0140-6736(18)32752-1"}],"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":"NCT01874171","phase":"3","setting":"Low-risk HPV-positive oropharyngeal cancer: radiotherapy with cetuximab versus radiotherapy with cisplatin","sponsor":"University of Warwick","result":"Severe toxicity similar; 2-year overall survival 97.5% (cisplatin) vs 89.4% (cetuximab).","started":"2012-11-15","startedType":"actual","yearReported":2019,"enrolled":334,"enrolledBasis":"registry","outcomes":[{"endpoint":"Severe (grade 3-5) toxicity events per patient at 24 months","primary":true,"unit":"events per patient","arms":[{"name":"Radiotherapy + cisplatin","n":166,"value":4.8},{"name":"Radiotherapy + cetuximab","n":168,"value":4.8}],"p":"0.98","source":"https://doi.org/10.1016/S0140-6736(18)32752-1"},{"endpoint":"Overall survival at 2 years","unit":"%","arms":[{"name":"Radiotherapy + cisplatin","value":97.5},{"name":"Radiotherapy + cetuximab","value":89.4}],"hr":5,"ci":[1.7,14.7],"p":"0.001","source":"https://doi.org/10.1016/S0140-6736(18)32752-1"},{"endpoint":"Recurrence at 2 years","unit":"%","arms":[{"name":"Radiotherapy + cisplatin","value":6},{"name":"Radiotherapy + cetuximab","value":16.1}],"hr":3.4,"ci":[1.6,7.2],"p":"0.0007","source":"https://doi.org/10.1016/S0140-6736(18)32752-1"}]},"route":"/trials/de-escalate/","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/"}],"paper":[{"id":"paper-de-escalate-lancet-2019","kind":"paper","name":"De-ESCALaTE HPV: radiotherapy plus cisplatin or cetuximab in low-risk HPV-positive oropharyngeal cancer","route":"/key-papers/paper-de-escalate-lancet-2019/"}]}}