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 Academic Article uri icon

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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.

authors

  • 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, James
  • Parker, Christina
  • Wehrli, Bret
  • Kwan, Keith
  • Theurer, Julie
  • Palma, David A

publication date

  • December 2020