Evidence map›Paper›PMID 32059705›Full record

ArticleBMC cancer2020

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, Sarah Hamilton, Jonn Wu, Kevin Fung, John R de Almeida, Andrew Bayley and 40 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
10.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03210103 naactive not recruitingnot on this map

A Randomized Trial of Treatment De-Escalation for HPV-Associated Oropharyngeal Squamous Cell Carcinoma: Radiotherapy vs. Trans-Oral Surgery (ORATOR II)

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2018 to 2028Enrolled61ConditionsOropharyngeal CancerArmsRadiation, Transoral Surgery (TOS) + Neck Dissection
NCT07337161 narecruitingnot on this mapstarted 2025, after this paper: background citation

Stereotactic Post-operative Radiotherapy for Intraparotid Metastatic Cutaneous Squamous Cell Carcinoma

TypeinterventionalSponsorDavid PalmaRan2025 to 2035Enrolled90ConditionsCutaneous, Head and Neck Cancer Squamous Cell CarcinomaArmsSBRT, Standard Radiation
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 74 citations in OpenAlex.

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  7. Overall survival, disease-free survival and quality of life in patients affected by HPV mediated p16+ oropharyngeal squamous cell carcinoma treated with upfront trans-oral robotic surgery vs radiotherapy or chemoradiotherapy.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

50 authors at 14 institutions in 2 countries.

Anthony C NicholsDepartment of Otolaryngology - Head and Neck Surgery, Western University, London, ON, Canada.
Pencilla LangDepartment of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada.
Eitan PrismanDivision of Otolaryngology - Head and Neck Surgery, University of British Columbia, Vancouver, BC, Canada.
Eric BertheletDepartment of Radiation Oncology, University of British Columbia, Vancouver, BC, Canada.
Eric TranDepartment of Radiation Oncology, University of British Columbia, Vancouver, BC, Canada.
Sarah HamiltonDepartment of Radiation Oncology, University of British Columbia, Vancouver, BC, Canada.
Jonn WuDepartment of Radiation Oncology, University of British Columbia, Vancouver, BC, Canada.
Kevin FungDepartment of Otolaryngology - Head and Neck Surgery, Western University, London, ON, Canada.
John R de AlmeidaDepartment of Otolaryngology - Head and Neck Surgery, University Health Network, University of Toronto, Toronto, ON, Canada.
Andrew BayleyDepartment of Radiation Oncology, University Health Network, University of Toronto, Toronto, ON, Canada.
David P GoldsteinDepartment of Otolaryngology - Head and Neck Surgery, University Health Network, University of Toronto, Toronto, ON, Canada.
Antoine EskanderDepartment of Otolaryngology - Head and Neck Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Zain HusainDepartment of Radiation Oncology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Houda BahigDepartment of Radiation Oncology, CHUM, Université de Montréal, Montreal, QC, Canada.
Apostolos ChristopoulousDepartment of Otorhinolaryngology - Head and Neck Surgery, CHUM, Université de Montréal, Montreal, QC, Canada.
Michael HierDepartment of Otolaryngology - Head and Neck Surgery, McGill University, Montreal, QC, Canada.
Khalil SultanemDepartment of Radiation Oncology, McGill University, Montreal, QC, Canada.
Keith RichardsonDepartment of Otolaryngology - Head and Neck Surgery, McGill University, Montreal, QC, Canada.
Alex MlynarekDepartment of Otolaryngology - Head and Neck Surgery, McGill University, Montreal, QC, Canada.
Suren KrishnanDepartment of Otolaryngology - Head and Neck Surgery, Royal Adelaide Hospital, Adelaide, Australia.
Hien LeDepartment of Radiation Oncology, Royal Adelaide Hospital, Adelaide, Australia.
John YooDepartment of Otolaryngology - Head and Neck Surgery, Western University, London, ON, Canada.
S Danielle MacNeilDepartment of Otolaryngology - Head and Neck Surgery, Western University, London, ON, Canada.
Adrian MendezDepartment of Otolaryngology - Head and Neck Surgery, Western University, London, ON, Canada.
Eric WinquistDepartment of Medical Oncology, Western University, London, ON, Canada.
Nancy ReadDepartment of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada.
Varagur VenkatesanDepartment of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada.
Sara KuruvillaDepartment of Medical Oncology, Western University, London, ON, Canada.
Andrew WarnerDepartment of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada.
Sylvia MitchellDepartment of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada.
Martin CorstenDivision of Otolaryngology - Head and Neck Surgery, Dalhousie University, Halifax, NS, Canada.
Murali RajaramanDivision of Otolaryngology - Head and Neck Surgery, Dalhousie University, Halifax, NS, Canada.
Stephanie Johnson-ObasekiDepartment of Otolaryngology - Head and Neck Surgery, University of Ottawa, Ottawa, ON, Canada.
Libni EapenDepartment of Radiation Oncology, University of Ottawa, Ottawa, ON, Canada.
Michael OdellDepartment of Otolaryngology - Head and Neck Surgery, University of Ottawa, Ottawa, ON, Canada.
Shamir ChandaranaSection of Otolaryngology - Head and Neck Surgery, University of Calgary, Calgary, AB, Canada.
Robyn BanerjeeDepartment of Radiation Oncology, University of Calgary, Calgary, AB, Canada.
Joseph DortSection of Otolaryngology - Head and Neck Surgery, University of Calgary, Calgary, AB, Canada.
T Wayne MatthewsSection of Otolaryngology - Head and Neck Surgery, University of Calgary, Calgary, AB, Canada.
Robert HartSection of Otolaryngology - Head and Neck Surgery, University of Calgary, Calgary, AB, Canada.
Paul KerrDepartment of Otolaryngology, University of Manitoba, Winnipeg, MB, Canada.
Samuel DowthwaiteDepartment of Otolaryngology - Head and Neck Surgery, Gold Coast University Hospital, Southport, Queensland, Australia.
Michael GuptaDivision of Otolaryngology - Head and Neck Surgery, McMaster University, Hamilton, ON, Canada.
Han ZhangDivision of Otolaryngology - Head and Neck Surgery, McMaster University, Hamilton, ON, Canada.
Jim WrightDepartment of Radiation Oncology, McMaster University, Hamilton, ON, Canada.
Christina ParkerDepartment of Audiology, London Health Sciences Centre, London, ON, Canada.
Bret WehrliDepartment of Pathology, Western University, London, ON, Canada.
Keith KwanDepartment of Pathology, Western University, London, ON, Canada.
Julie TheurerSchool of Communication Sciences and Disorders, Western University, London, ON, Canada.
David A PalmaDepartment of Radiation Oncology, London Health Sciences Centre, Western University, 800 Commissioners Rd. E, London, Ontario, N6A 5W9, Canada. david.palma@lhsc.on.ca.ORCID http://orcid.org/0000-0002-9542-0627
Western University · CAUniversity of British Columbia · CAUniversity of Calgary · CAMcGill University · CAMcMaster University · CAUniversity Health Network · CAUniversity of Ottawa · CADalhousie University · CARoyal Adelaide Hospital · AUSunnybrook Health Science Centre · CAUniversité de Montréal · CAGold Coast Hospital · AULondon Health Sciences Centre · CAUniversity of Manitoba · CA

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

backgroundPatients 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.

methodsThis 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 registrationClinicaltrials.gov identifier: NCT03210103. Date of registration: July 6, 2017, Current version: 1.3 on March 15, 2019.

Indexed as

Carcinoma, Squamous CellOral Surgical ProceduresOropharyngeal NeoplasmsPapillomavirus InfectionsRadiotherapy, AdjuvantClinical Trials, Phase II as TopicCombined Modality TherapyFemaleHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicResearch DesignDe-escalationHead and neck cancerHuman papillomavirusOropharynxQuality of LifeRadiotherapyRandomized controlled trialSurvivalTransoral surgery

Identifiers

PMID32059705
PMCPMC7023689
OpenAlexW3005641209

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.