Wiegand, Susanne and Wichmann, Gunnar and Vogt, Jeannette and Vogel, Kathrin and Franke, Annegret and Kuhnt, Thomas and Lordick, Florian and Scheuble, Anne-Marie and Hambsch, Peter and Brossart, Peter and Bauernfeind, Franz Georg and Kaftan, Holger and Maschmeyer, Georg and Paland, Matthias and Muenter, Marc and Lewitzki, Victor and Rotter, Nicole and Stromberger, Carmen and Beck, Marcus and Dommerich, Steffen and Gauler, Thomas Christoph and Hapke, Gunnar and Guntinas-Lichius, Orlando and Schroeder, Ursula and Goerner, Martin and Hautmann, Matthias G. and Steger, Felix and Tamaskovics, Balint and Schmiedeknecht, Anett and Dietz, Andreas (2023) 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. FRONTIERS IN ONCOLOGY, 13: 1128176. ISSN 2234-943X,
Full text not available from this repository. (Request a copy)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 survival 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 hundred 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | OPEN-LABEL; NCIC CTG; RISK; CHEMOTHERAPY; RADIOTHERAPY; RECURRENT; EORTC; RTOG; MULTICENTER; DELINEATION; head neck cancer; immunotherapy; pembrolizumab; immune checkpoint blockade PD-1:PD-L1 axis; upfront surgery; locoregional disease; randomized controlled phase IIB clinical trial |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Strahlentherapie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 18 Apr 2024 12:39 |
| Last Modified: | 18 Apr 2024 12:39 |
| URI: | https://pred.uni-regensburg.de/id/eprint/60810 |
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