Browsing by Author "Goldstein, David P"

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    Treatment de-escalation for HPV-associated oropharyngeal squamous cell carcinoma with radiotherapy vs. trans-oral surgery (ORATOR2): study protocol for a randomized phase II trial
    (2020-02-14) Nichols, Anthony C; Lang, Pencilla; Prisman, Eitan; Berthelet, Eric; Tran, Eric; Hamilton, Sarah; Wu, Jonn; Fung, Kevin; de Almeida, John R; Bayley, Andrew; Goldstein, David P; Eskander, Antoine; Husain, Zain; Bahig, Houda; Christopoulous, Apostolos; Hier, Michael; Sultanem, Khalil; Richardson, Keith; Mlynarek, Alex; Krishnan, Suren; Le, Hien; Yoo, John; MacNeil, S. D; Mendez, Adrian; Winquist, Eric; Read, Nancy; Venkatesan, Varagur; Kuruvilla, Sara; Warner, Andrew; Mitchell, Sylvia; Corsten, Martin; Rajaraman, Murali; Johnson-Obaseki, Stephanie; Eapen, Libni; Odell, Michael; Chandarana, Shamir; Banerjee, Robyn; Dort, Joseph; Matthews, T. W; Hart, Robert; Kerr, Paul; Dowthwaite, Samuel; Gupta, Michael; Zhang, Han; Wright, Jim; Parker, Christina; Wehrli, Bret; Kwan, Keith; Theurer, Julie; Palma, David A
    Abstract Background Patients with human papillomavirus-positive (HPV+) oropharyngeal squamous cell carcinoma (OPC) have substantially better treatment response and overall survival (OS) than patients with HPV-negative disease. Treatment options for HPV+ OPC can involve either a primary radiotherapy (RT) approach (± concomitant chemotherapy) or a primary surgical approach (± adjuvant radiation) with transoral surgery (TOS). These two treatment paradigms have different spectrums of toxicity. The goals of this study are to assess the OS of two de-escalation approaches (primary radiotherapy and primary TOS) compared to historical control, and to compare survival, toxicity and quality of life (QOL) profiles between the two approaches. Methods This is a multicenter phase II study randomizing one hundred and forty patients with T1–2 N0–2 HPV+ OPC in a 1:1 ratio between de-escalated primary radiotherapy (60 Gy) ± concomitant chemotherapy and TOS ± de-escalated adjuvant radiotherapy (50–60 Gy based on risk factors). Patients will be stratified based on smoking status (< 10 vs. ≥ 10 pack-years). The primary endpoint is OS of each arm compared to historical control; we hypothesize that a 2-year OS of 85% or greater will be achieved. Secondary endpoints include progression free survival, QOL and toxicity. Discussion This study will provide an assessment of two de-escalation approaches to the treatment of HPV+ OPC on oncologic outcomes, QOL and toxicity. Results will inform the design of future definitive phase III trials. Trial Registration Clinicaltrials.gov identifier: NCT03210103. Date of registration: July 6, 2017, Current version: 1.3 on March 15, 2019.