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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.
  • 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 en En | MEDLINE | ID: mdl-32059705
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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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Carcinoma de Células Escamosas / Neoplasias Orofaríngeas / Protocolos Clínicos / Radioterapia Adyuvante / Procedimientos Quirúrgicos Orales / Infecciones por Papillomavirus Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline / Prognostic_studies / Risk_factors_studies Límite: Female / Humans / Male Idioma: En Año: 2020 Tipo del documento: Article
Texto completo
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Carcinoma de Células Escamosas / Neoplasias Orofaríngeas / Protocolos Clínicos / Radioterapia Adyuvante / Procedimientos Quirúrgicos Orales / Infecciones por Papillomavirus Tipo de estudio: Clinical_trials / Diagnostic_studies / Guideline / Prognostic_studies / Risk_factors_studies Límite: Female / Humans / Male Idioma: En Año: 2020 Tipo del documento: Article