DOAJ Open Access 2020

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

Anthony C. Nichols Pencilla Lang Eitan Prisman Eric Berthelet Eric Tran +45 lainnya

Abstrak

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.

Topik & Kata Kunci

Neoplasms. Tumors. Oncology. Including cancer and carcinogens

Penulis (50)

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

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

Format Sitasi

APA MLA BibTeX

Nichols, A.C., Lang, P., Prisman, E., Berthelet, E., Tran, E., Hamilton, S. et al. (2020). 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. https://doi.org/10.1186/s12885-020-6607-z

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Informasi Jurnal

Tahun Terbit: 2020
Sumber Database: DOAJ
DOI: 10.1186/s12885-020-6607-z
Akses: Open Access ✓