Evidence map›Paper›PMID 31416685›Full record

Trial reportThe Lancet. Oncology2019

Radiotherapy versus transoral robotic surgery and neck dissection for oropharyngeal squamous cell carcinoma (ORATOR): an open-label, phase 2, randomised trial.

Anthony C Nichols, Julie Theurer, Eitan Prisman, Nancy Read, Eric Berthelet, Eric Tran, Kevin Fung, John R de Almeida, Andrew Bayley, David P Goldstein and 23 more

Erratum issued 2 registry-linked trialsAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The Lancet. Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 208 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
208citing papers in PubMed, 18 pooled it
47.9field-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.

NCT01590355 phase2unknown statusnot on this map

A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2012 to 2023Enrolled68ConditionsEarly-Stage Squamous Cell Carcinoma of the OropharynxArmsRadiotherapy, Transoral Robotic Surgery + Neck Dissection
NCT05144100 phase2 / phase3not yet recruitingnot on this mapstarted 2021, after this paper: background citation

Primary Surgery Vs Primary Chemoradiation for Oropharyngeal Cancer (Scope Trial) - A Phase II/III Integrated Design Randomized Control Trial

TypeinterventionalSponsorTata Memorial CentreRan2021 to 2031Enrolled498ConditionsStage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8ArmsSurgery with or without Neck Dissection, Radiation, Cisplatin based chemotherpay
3 · Its place in the literature

Who cites it

208 citing papers in PubMed, 18 syntheses or guidelines pooled it, 453 citations in OpenAlex.

  1. Pooled it
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  3. SEOM-TTCC clinical guidelines for the treatment of head and neck cancer (2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Guideline
  4. Pooled it
  5. A Meta-analysis of Functional Outcomes and Recovery Metrics Comparing Transoral Robotic Surgery and (Chemo)Radiotherapy.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2026
    Pooled it
  6. Pooled it
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  8. Guideline
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  13. The relevance of ototoxicity induced by radiotherapy.Radiation oncology (London, England) · 2023
    Pooled it
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  16. Transoral robotic surgery and intensity-modulated radiotherapy in the treatment of the oropharyngeal carcinoma: a systematic review and meta-analysis.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 · 2021
    Pooled it
  17. SEOM clinical guidelines for the treatment of head and neck cancer (2020).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021
    Guideline
  18. Pooled it
  19. Trial
  20. Trial

148 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

33 authors at 8 institutions in 2 countries.

Anthony C NicholsDepartment of Otolaryngology-Head and Neck Surgery, Western University, London, ON, Canada. Electronic address: anthony.nichols@lhsc.on.ca.
Julie TheurerSchool of Communication Sciences and Disorders, Western University, London, ON, Canada.
Eitan PrismanDepartment of Otolaryngology, University of British Columbia, Vancouver, BC, Canada.
Nancy ReadDepartment of Radiation Oncology, Western University, London, ON, 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.
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.
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.
Eric WinquistDepartment of Medical Oncology, Western University, London, ON, Canada.
J Alex HammondDepartment of Radiation Oncology, Western University, London, ON, Canada.
Varagur VenkatesanDepartment of Radiation Oncology, Western University, London, ON, Canada.
Sara KuruvillaDepartment of Medical Oncology, Western University, London, ON, Canada.
Andrew WarnerDepartment of Radiation Oncology, Western University, London, ON, Canada.
Sylvia MitchellDepartment of Radiation Oncology, Western University, London, ON, Canada.
Jeff ChenDepartment of Radiation Oncology, Western University, London, ON, Canada.
Martin CorstenDepartment of Otolaryngology-Head and Neck Surgery, University of Ottawa, Ottawa, ON, 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.
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.
David A PalmaDepartment of Radiation Oncology, Western University, London, ON, Canada.
Western University · CAMcGill University · CAUniversity of Ottawa · CAUniversity of British Columbia · CARoyal Adelaide Hospital · AUUniversity of Toronto · CALondon Health Sciences Centre · CAUniversity Health Network · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTransoral robotic surgery (TORS) with concurrent neck dissection has supplanted radiotherapy in the USA as the most common treatment for oropharyngeal squamous cell carcinoma (OPSCC), yet no randomised trials have compared these modalities. We aimed to evaluate differences in quality of life (QOL) 1 year after treatment.

methodsThe ORATOR trial was an investigator-initiated, multicentre, international, open-label, parallel-group, phase 2, randomised study. Patients were enrolled at six hospitals in Canada and Australia. We randomly assigned (1:1) patients aged 18 years or older, with Eastern Cooperative Oncology Group scores of 0-2, and with T1-T2, N0-2 (≤4 cm) OPSCC tumour types to radiotherapy (70 Gy, with chemotherapy if N1-2) or TORS plus neck dissection (with or without adjuvant chemoradiotherapy, based on pathology). Following stratification by p16 status, patients were randomly assigned using a computer-generated randomisation list with permuted blocks of four. The primary endpoint was swallowing-related QOL at 1 year as established using the MD Anderson Dysphagia Inventory (MDADI) score, powered to detect a 10-point improvement (a clinically meaningful change) in the TORS plus neck dissection group. All analyses were done by intention to treat. This study is registered with ClinicalTrials.gov (NCT01590355) and is active, but not currently recruiting.

findings68 patients were randomly assigned (34 per group) between Aug 10, 2012, and June 9, 2017. Median follow-up was 25 months (IQR 20-33) for the radiotherapy group and 29 months (23-43) for the TORS plus neck dissection group. MDADI total scores at 1 year were mean 86·9 (SD 11·4) in the radiotherapy group versus 80·1 (13·0) in the TORS plus neck dissection group (p=0·042). There were more cases of neutropenia (six [18%] of 34 patients vs none of 34), hearing loss (13 [38%] vs five [15%]), and tinnitus (12 [35%] vs two [6%]) reported in the radiotherapy group than in the TORS plus neck dissection group, and more cases of trismus in the TORS plus neck dissection group (nine [26%] vs one [3%]). The most common adverse events in the radiotherapy group were dysphagia (n=6), hearing loss (n=6), and mucositis (n=4), all grade 3, and in the TORS plus neck dissection group, dysphagia (n=9, all grade 3) and there was one death caused by bleeding after TORS.

interpretationPatients treated with radiotherapy showed superior swallowing-related QOL scores 1 year after treatment, although the difference did not represent a clinically meaningful change. Toxicity patterns differed between the groups. Patients with OPSCC should be informed about both treatment options.

fundingCanadian Cancer Society Research Institute Grant (#701842), Ontario Institute for Cancer Research Clinician-Scientist research grant, and the Wolfe Surgical Research Professorship in the Biology of Head and Neck Cancers grant.

Indexed as

Quality of LifeAgedChemoradiotherapy, AdjuvantDeglutitionDeglutition DisordersFemaleHearing LossHumansIntention to Treat AnalysisMaleMiddle AgedNeck DissectionNeutropeniaRadiotherapy, Intensity-ModulatedRobotic Surgical ProceduresSquamous Cell Carcinoma of Head and Neck

Identifiers

PMID31416685
OpenAlexW2967453129

What OpenQuestion holds

Textmetadata
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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.