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.

Authors

Anthony C Nichols
Pencilla Lang
Eitan Prisman
Eric Berthelet
Eric Tran
Sarah Hamilton
Jonn Wu
Kevin Fung
John R de Almeida
Andrew Bayley
David P Goldstein
Antoine Eskander
Zain Husain
Houda Bahig
Apostolos Christopoulous
Michael Hier
Khalil Sultanem
Keith Richardson
Alex Mlynarek
Suren Krishnan
Hien Le
John Yoo, Western UniversityFollow
S Danielle MacNeil
Adrian Mendez
Eric Winquist
Nancy Read
Varagur Venkatesan
Sara Kuruvilla
Andrew Warner
Sylvia Mitchell
Martin Corsten
Murali Rajaraman
Stephanie Johnson-Obaseki
Libni Eapen
Michael Odell
Shamir Chandarana
Robyn Banerjee
Joseph Dort
T Wayne Matthews
Robert Hart
Paul Kerr
Samuel Dowthwaite
Michael Gupta
Han Zhang
Jim Wright
Christina Parker
Bret Wehrli
Keith Kwan
Julie Theurer
David A Palma

Document Type

Article

Publication Date

2-14-2020

Journal

BMC Cancer

Volume

20

Issue

1

First Page

125

Last Page

125

URL with Digital Object Identifier

https://doi.org/10.1186/s12885-020-6607-z.

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.

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