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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

  • Nichols, Anthony C.1
  • Lang, Pencilla2
  • Prisman, Eitan3
  • Berthelet, Eric3
  • Tran, Eric3
  • Hamilton, Sarah3
  • Wu, Jonn3
  • Fung, Kevin1
  • de Almeida, John R.4
  • Bayley, Andrew4
  • Goldstein, David P.4
  • Eskander, Antoine5
  • Husain, Zain5
  • Bahig, Houda6
  • Christopoulous, Apostolos6
  • Hier, Michael7
  • Sultanem, Khalil7
  • Richardson, Keith7
  • Mlynarek, Alex7
  • Krishnan, Suren8
  • And 30 more
  • 1 Western University, London, ON, Canada , London (Canada)
  • 2 Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada , London (Canada)
  • 3 University of British Columbia, Vancouver, BC, Canada , Vancouver (Canada)
  • 4 University Health Network, University of Toronto, Toronto, ON, Canada , Toronto (Canada)
  • 5 University of Toronto, Toronto, ON, Canada , Toronto (Canada)
  • 6 Université de Montréal, Montreal, QC, Canada , Montreal (Canada)
  • 7 McGill University, Montreal, QC, Canada , Montreal (Canada)
  • 8 Royal Adelaide Hospital, Adelaide, Australia , Adelaide (Australia)
  • 9 Dalhousie University, Halifax, NS, Canada , Halifax (Canada)
  • 10 University of Ottawa, Ottawa, ON, Canada , Ottawa (Canada)
  • 11 University of Calgary, Calgary, AB, Canada , Calgary (Canada)
  • 12 University of Manitoba, Winnipeg, MB, Canada , Winnipeg (Canada)
  • 13 Gold Coast University Hospital, Southport, Queensland, Australia , Southport (Australia)
  • 14 McMaster University, Hamilton, ON, Canada , Hamilton (Canada)
  • 15 London Health Sciences Centre, London, ON, Canada , London (Canada)
Published Article
BMC Cancer
Springer (Biomed Central Ltd.)
Publication Date
Feb 14, 2020
DOI: 10.1186/s12885-020-6607-z
Springer Nature


BackgroundPatients 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.MethodsThis 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.DiscussionThis 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 identifier: NCT03210103. Date of registration: July 6, 2017, Current version: 1.3 on March 15, 2019.

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