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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; 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.
Afiliação
  • Nichols AC; Department of Otolaryngology - Head and Neck Surgery, Western University, London, ON, Canada.
  • Lang P; Department of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada.
  • Prisman E; Division of Otolaryngology - Head and Neck Surgery, University of British Columbia, Vancouver, BC, Canada.
  • Berthelet E; Department of Radiation Oncology, University of British Columbia, Vancouver, BC, Canada.
  • Tran E; Department of Radiation Oncology, University of British Columbia, Vancouver, BC, Canada.
  • Hamilton S; Department of Radiation Oncology, University of British Columbia, Vancouver, BC, Canada.
  • Wu J; Department of Radiation Oncology, University of British Columbia, Vancouver, BC, Canada.
  • Fung K; Department of Otolaryngology - Head and Neck Surgery, Western University, London, ON, Canada.
  • de Almeida JR; Department of Otolaryngology - Head and Neck Surgery, University Health Network, University of Toronto, Toronto, ON, Canada.
  • Bayley A; Department of Radiation Oncology, University Health Network, University of Toronto, Toronto, ON, Canada.
  • Goldstein DP; Department of Otolaryngology - Head and Neck Surgery, University Health Network, University of Toronto, Toronto, ON, Canada.
  • Eskander A; Department of Otolaryngology - Head and Neck Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
  • Husain Z; Department of Radiation Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
  • Bahig H; Department of Radiation Oncology, CHUM, Université de Montréal, Montreal, QC, Canada.
  • Christopoulous A; Department of Otorhinolaryngology - Head and Neck Surgery, CHUM, Université de Montréal, Montreal, QC, Canada.
  • Hier M; Department of Otolaryngology - Head and Neck Surgery, McGill University, Montreal, QC, Canada.
  • Sultanem K; Department of Radiation Oncology, McGill University, Montreal, QC, Canada.
  • Richardson K; Department of Otolaryngology - Head and Neck Surgery, McGill University, Montreal, QC, Canada.
  • Mlynarek A; Department of Otolaryngology - Head and Neck Surgery, McGill University, Montreal, QC, Canada.
  • Krishnan S; Department of Otolaryngology - Head and Neck Surgery, Royal Adelaide Hospital, Adelaide, Australia.
  • Le H; Department of Radiation Oncology, Royal Adelaide Hospital, Adelaide, Australia.
  • Yoo J; Department of Otolaryngology - Head and Neck Surgery, Western University, London, ON, Canada.
  • MacNeil SD; Department of Otolaryngology - Head and Neck Surgery, Western University, London, ON, Canada.
  • Mendez A; Department of Otolaryngology - Head and Neck Surgery, Western University, London, ON, Canada.
  • Winquist E; Department of Medical Oncology, Western University, London, ON, Canada.
  • Read N; Department of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada.
  • Venkatesan V; Department of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada.
  • Kuruvilla S; Department of Medical Oncology, Western University, London, ON, Canada.
  • Warner A; Department of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada.
  • Mitchell S; Department of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada.
  • Corsten M; Division of Otolaryngology - Head and Neck Surgery, Dalhousie University, Halifax, NS, Canada.
  • Rajaraman M; Division of Otolaryngology - Head and Neck Surgery, Dalhousie University, Halifax, NS, Canada.
  • Johnson-Obaseki S; Department of Otolaryngology - Head and Neck Surgery, University of Ottawa, Ottawa, ON, Canada.
  • Eapen L; Department of Radiation Oncology, University of Ottawa, Ottawa, ON, Canada.
  • Odell M; Department of Otolaryngology - Head and Neck Surgery, University of Ottawa, Ottawa, ON, Canada.
  • Chandarana S; Section of Otolaryngology - Head and Neck Surgery, University of Calgary, Calgary, AB, Canada.
  • Banerjee R; Department of Radiation Oncology, University of Calgary, Calgary, AB, Canada.
  • Dort J; Section of Otolaryngology - Head and Neck Surgery, University of Calgary, Calgary, AB, Canada.
  • Matthews TW; Section of Otolaryngology - Head and Neck Surgery, University of Calgary, Calgary, AB, Canada.
  • Hart R; Section of Otolaryngology - Head and Neck Surgery, University of Calgary, Calgary, AB, Canada.
  • Kerr P; Department of Otolaryngology, University of Manitoba, Winnipeg, MB, Canada.
  • Dowthwaite S; Department of Otolaryngology - Head and Neck Surgery, Gold Coast University Hospital, Southport, Queensland, Australia.
  • Gupta M; Division of Otolaryngology - Head and Neck Surgery, McMaster University, Hamilton, ON, Canada.
  • Zhang H; Division of Otolaryngology - Head and Neck Surgery, McMaster University, Hamilton, ON, Canada.
  • Wright J; Department of Radiation Oncology, McMaster University, Hamilton, ON, Canada.
  • Parker C; Department of Audiology, London Health Sciences Centre, London, ON, Canada.
  • Wehrli B; Department of Pathology, Western University, London, ON, Canada.
  • Kwan K; Department of Pathology, Western University, London, ON, Canada.
  • Theurer J; School of Communication Sciences and Disorders, Western University, London, ON, Canada.
  • Palma DA; Department of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada. david.palma@lhsc.on.ca.
BMC Cancer ; 20(1): 125, 2020 Feb 14.
Article em En | MEDLINE | ID: mdl-32059705
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 11 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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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Carcinoma de Células Escamosas / Neoplasias Orofaríngeas / Protocolos Clínicos / Radioterapia Adjuvante / Procedimentos Cirúrgicos Bucais / Infecções por Papillomavirus Idioma: En Ano de publicação: 2020 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Carcinoma de Células Escamosas / Neoplasias Orofaríngeas / Protocolos Clínicos / Radioterapia Adjuvante / Procedimentos Cirúrgicos Bucais / Infecções por Papillomavirus Idioma: En Ano de publicação: 2020 Tipo de documento: Article