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{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,3,22]],"date-time":"2023-03-22T05:14:20Z","timestamp":1679462060051},"reference-count":20,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,3,21]],"date-time":"2023-03-21T00:00:00Z","timestamp":1679356800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Oncol."],"abstract":"<jats:p>Most of the patients with head and neck squamous cell carcinoma (HNSCC) are diagnosed with locally advanced disease. Standards of care for curative-intent treatment of this patient group are either surgery and adjuvant radio(chemo)therapy (aRCT) or definitive chemoradiation. Despite these treatments, especially pathologically intermediate and high-risk HNSCC often recur. The ADRISK trial investigates in locally advanced HNSCC and intermediate and high risk after up-front surgery if the addition of pembrolizumab to aRCT with cisplatin improves event-free sur-vival compared to aRCT alone. ADRISK is a prospective, randomized controlled investiga-tor-initiated (IIT)-phase II multicenter trial within the German Interdisciplinary Study Group of German Cancer Society (IAG-KHT). Patients with primary resectable stage III and IV HNSCC of the oral cavity, oropharynx, hypopharynx and larynx with pathologic high (R1, extracapsular nodal extension) or intermediate risk (R0 &lt;5 mm; N\u22652) after surgery will be eligible. Two hun-dred forty patients will be randomly assigned (1:1) to either standard aRCT with cisplatin (standard arm) or aRCT with cisplatin + pembrolizumab (200 mg iv, in 3-week cycle, max. 12 months) (interventional arm). Endpoints are event-free and overall survival. Recruitment started in August 2018 and is ongoing.<\/jats:p>","DOI":"10.3389\/fonc.2023.1128176","type":"journal-article","created":{"date-parts":[[2023,3,21]],"date-time":"2023-03-21T06:09:57Z","timestamp":1679378997000},"update-policy":"http:\/\/dx.doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Postoperative adjuvant radiochemotherapy with cisplatin versus adjuvant radiochemotherapy with cisplatin and pembrolizumab in locally advanced head and neck squamous cell carcinoma- the study protocol of the Adrisk trial"],"prefix":"10.3389","volume":"13","author":[{"given":"Susanne","family":"Wiegand","sequence":"first","affiliation":[]},{"given":"Gunnar","family":"Wichmann","sequence":"additional","affiliation":[]},{"given":"Jeannette","family":"Vogt","sequence":"additional","affiliation":[]},{"given":"Kathrin","family":"Vogel","sequence":"additional","affiliation":[]},{"given":"Annegret","family":"Franke","sequence":"additional","affiliation":[]},{"given":"Thomas","family":"Kuhnt","sequence":"additional","affiliation":[]},{"given":"Florian","family":"Lordick","sequence":"additional","affiliation":[]},{"given":"Anne-Marie","family":"Scheuble","sequence":"additional","affiliation":[]},{"given":"Peter","family":"Hambsch","sequence":"additional","affiliation":[]},{"given":"Peter","family":"Brossart","sequence":"additional","affiliation":[]},{"given":"Franz Georg","family":"Bauernfeind","sequence":"additional","affiliation":[]},{"given":"Holger","family":"Kaftan","sequence":"additional","affiliation":[]},{"given":"Georg","family":"Maschmeyer","sequence":"additional","affiliation":[]},{"given":"Matthias","family":"Paland","sequence":"additional","affiliation":[]},{"given":"Marc","family":"M\u00fcnter","sequence":"additional","affiliation":[]},{"given":"Victor","family":"Lewitzki","sequence":"additional","affiliation":[]},{"given":"Nicole","family":"Rotter","sequence":"additional","affiliation":[]},{"given":"Carmen","family":"Stromberger","sequence":"additional","affiliation":[]},{"given":"Marcus","family":"Beck","sequence":"additional","affiliation":[]},{"given":"Steffen","family":"Dommerich","sequence":"additional","affiliation":[]},{"given":"
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