AUTHOR=Wiegand Susanne , Wichmann Gunnar , Vogt Jeannette , Vogel Kathrin , Franke Annegret , Kuhnt Thomas , Lordick Florian , Scheuble Anne-Marie , Hambsch Peter , Brossart Peter , Bauernfeind Franz Georg , Kaftan Holger , Maschmeyer Georg , Paland Matthias , Münter Marc , Lewitzki Victor , Rotter Nicole , Stromberger Carmen , Beck Marcus , Dommerich Steffen , Gauler Thomas Christoph , Hapke Gunnar , Guntinas-Lichius Orlando , Schröder Ursula , Görner Martin , Hautmann Matthias G. , Steger Felix , Tamaskovics Bálint , Schmiedeknecht Anett , Dietz Andreas 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 JOURNAL=Frontiers in Oncology VOLUME=13 YEAR=2023 URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1128176 DOI=10.3389/fonc.2023.1128176 ISSN=2234-943X ABSTRACT=

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 <5 mm; N≥2) 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.