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
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Published:2020-02-14
Issue:1
Volume:20
Page:
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ISSN:1471-2407
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Container-title:BMC Cancer
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language:en
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Short-container-title:BMC Cancer
Author:
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. Danielle, 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. Wayne, Hart Robert, Kerr Paul, Dowthwaite Samuel, Gupta Michael, Zhang Han, Wright Jim, Parker Christina, Wehrli Bret, Kwan Keith, Theurer Julie, Palma David A.ORCID
Abstract
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.
Funder
London Health Sciences Foundation Ontario Institute for Cancer Research London Health Sciences Centre - department of otolaryngology head and neck surgery Canadian Cancer Clinical Trials Network
Publisher
Springer Science and Business Media LLC
Subject
Cancer Research,Genetics,Oncology
Reference26 articles.
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