Robert L Ferris, Yael Flamand, F Christopher Holsinger, Gregory S Weinstein, Harry Quon, Ranee Mehra, Joaquin J Garcia, Michael L Hinni, Neil D Gross, Erich M Sturgis, Umamaheswar Duvvuri, Eduardo Méndez, John A Ridge, J Scott Magnuson, Kerry A Higgins, Mihir R Patel, Russel B Smith, Daniel W Karakla, Michael E Kupferman, James P Malone, Benjamin L Judson, Jeremy Richmon, Jay O Boyle, Rodrigo Bayon, Bert W O'Malley, Enver Ozer, Giovana R Thomas, Wayne M Koch, R Bryan Bell, Nabil F Saba, Shuli Li, Elin R Sigurdson, Barbara Burtness
PURPOSE: Understanding the role of transoral surgery in oropharyngeal cancer (OPC) requires prospective, randomized multi-institutional data. Meticulous evaluation of surgeon expertise and surgical quality assurance (QA) will be critical to the validity of such trials. We describe a novel surgeon credentialing and QA process developed to support the ECOG-ACRIN Cancer Research Group E3311 (E3311) and report outcomes related to QA. PATIENTS AND METHODS: E3311 was a phase II randomized clinical trial of transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC...
November 2020: Oral Oncology