Evidence map›Paper›PMID 26311526›Full record

Trial reportBMC cancer2015

PATHOS: a phase II/III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV) positive oropharyngeal cancer.

Waheeda Owadally, Chris Hurt, Hayley Timmins, Emma Parsons, Sarah Townsend, Joanne Patterson, Katherine Hutcheson, Ned Powell, Matthew Beasley, Nachi Palaniappan and 3 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2015. 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 131 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
131citing papers in PubMed, 9 pooled it
15.1field-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.

NCT02215265 phase3active not recruitingnot on this map

A Phase III Trial of Risk-stratified, Reduced Intensity Adjuvant Treatment in Patients Undergoing Transoral Surgery for Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer

TypeinterventionalSponsorLisette NixonRan2015 to 2028Enrolled1,269ConditionsHuman Papillomavirus (HPV)-Positive Oropharyngeal CancerArmsCisplatin, Postoperative radiotherapy
NCT05477992 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Haemorrhage Risk Reduction Using Endovascular Embolisation in Place of Vessel Ligation for Patients Undergoing Transoral Robotic Surgery (HELPR)

TypeinterventionalSponsorRoyal Marsden NHS Foundation TrustRan2022 to 2023Enrolled10ConditionsHead and Neck CancerArmsEndovascular embolization
3 · Its place in the literature

Who cites it

131 citing papers in PubMed, 9 syntheses or guidelines pooled it, 251 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Functional and quality-of-life outcomes following salvage surgery for recurrent squamous cell carcinoma of the head and neck: 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 · 2023
    Pooled it
  5. Pooled it
  6. 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
  7. A systematic review on Transoral robotic surgery (TORS) for carcinoma of unknown primary origin: Has tongue base mucosectomy become indispensable?Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery · 2020
    Pooled it
  8. Pooled it
  9. Pooled it
  10. Trial
  11. Trial
  12. Primary transoral robotic surgery with concurrent neck dissection for early stage oropharyngeal squamous cell carcinoma implemented at a Danish head and neck cancer center: a phase II trial on feasibility and tumour margin status.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 · 2017
    Trial
  13. Trial
  14. Trial
  15. Review
  16. Article
  17. Article
  18. Review
  19. Observational
  20. Article

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

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

13 authors at 7 institutions in 2 countries.

Waheeda OwadallyVelindre NHS Trust, Velindre Road, Cardiff, CF14 2TL, UK. waheedaowadally@nhs.net.
Chris HurtWales Cancer Trials Unit, 6th Floor, Neuadd Meirionnydd, Cardiff University, Heath Park, Cardiff, CF14 4YS, UK. HurtCN@cardiff.ac.uk.
Hayley TimminsWales Cancer Trials Unit, 6th Floor, Neuadd Meirionnydd, Cardiff University, Heath Park, Cardiff, CF14 4YS, UK. TimminsH@cardiff.ac.uk.
Emma ParsonsMount Vernon Hospital, Rickmansworth Road, Northwood, HA6 2RN, UK. eparsons1@nhs.net.
Sarah TownsendResearch and Development Office, 3rd Floor, Velindre NHS Trust, 14 Cathedral Road, Cardiff, CF11 9LJ, UK. Sarah.Townsend@wales.nhs.uk.
Joanne PattersonInstitute of Health and Society, Newcastle University, The Baddiley-Clark Building, Richardson Road, Newcastle-upon-Tyne, NE2 4AX, UK. joanne.patterson@newcastle.ac.uk.
Katherine HutchesonSpeech and Language Therapy, Department of Head and Neck Surgery, Section of Speech Pathology and Audiology, MD Anderson Cancer Centre, Houston, Texas, USA. karnold@mdanderson.org.
Ned PowellHPV Research Group, Section of Pathology, Cardiff University School of Medicine, UHW Main Building, Heath Park, Cardiff, CF14 4XN, UK. PowellNG@cardiff.ac.uk.
Matthew BeasleyBristol Cancer Institute, University Hospitals Bristol NHS Foundation Trust, Horfield Road, Bristol, BS2 8ED, UK. Matthew.Beasley@UHBristol.nhs.uk.
Nachi PalaniappanVelindre NHS Trust, Velindre Road, Cardiff, CF14 2TL, UK. Nachi.Palaniappan@wales.nhs.uk.
Max RobinsonCentre for Oral Health Research, Newcastle University, Framlington Place, Newcastle-upon-Tyne, NE2 4BW, UK. max.robinson@newcastle.ac.uk.
Terence M JonesHead and Neck Surgery, Department of Molecular and Clinical Cancer Medicine, Institute of Translational Medicine, University of Liverpool, 200 London Road, Liverpool, L3 9TA, UK. T.M.Jones@liverpool.ac.uk.
Mererid EvansVelindre NHS Trust, Velindre Road, Cardiff, CF14 2TL, UK. Mererid.Evans@wales.nhs.trust.
Velindre NHS Trust · GBCardiff University · GBNewcastle University · GBMount Vernon Hospital · GBThe University of Texas MD Anderson Cancer Center · USUniversity Hospitals Bristol NHS Foundation Trust · GBUniversity of Liverpool · GB

Funding

Cancer Research UK 15954Cancer Research UK 17161Cancer Research UK CRUK/13/025Department of Health CAT-CL-03-2012-004Medical Research Council MR/N005872/1
6 · The paper itself

Abstract

backgroundHuman papillomavirus-positive oropharyngeal squamous cell carcinoma is increasing in incidence worldwide. Current treatments are associated with high survival rates but often result in significant long-term toxicities. In particular, long-term dysphagia has a negative impact on patient quality of life and health. The aim of PATHOS is to determine whether reducing the intensity of adjuvant treatment after minimally invasive transoral surgery in this favourable prognosis disease will result in better long-term swallowing function whilst maintaining excellent disease-specific survival outcomes. METHODS/

designThe study is a multicentre phase II/III randomised controlled trial for patients with biopsy-proven Human papillomavirus-positive oropharyngeal squamous cell cancer staged T1-T3 N0-N2b with a primary tumour that is resectable via a transoral approach. Following transoral surgery and neck dissection, patients are allocated into three groups based on pathological risk factors for recurrence. Patients in the low-risk pathology group will receive no adjuvant treatment, as in standard practice. Patients in the intermediate-risk pathology group will be randomised to receive either standard dose post-operative radiotherapy (control) or reduced dose radiotherapy. Patients in the high-risk pathology group will be randomised to receive either post-operative chemoradiotherapy (control) or radiotherapy alone. The primary outcome of the phase II study is patient reported swallowing function measured using the MD Anderson Dysphagia Inventory score at 12 months post-treatment. If the phase II study is successful, PATHOS will proceed to a phase III non-inferiority trial with overall survival as the primary endpoint. DISCUSSION: PATHOS is a prospective, randomised trial for Human papillomavirus-positive oropharyngeal cancer, which represents a different disease entity compared with other head and neck cancers. The trial aims to demonstrate that long-term dysphagia can be lessened by reducing the intensity of adjuvant treatment without having a negative impact on clinical outcome. The study will standardise transoral surgery and post-operative intensity-modulated radiotherapy protocols in the UK and develop a gold-standard swallowing assessment panel. An associated planned translational research programme, underpinned by tumour specimens and sequential blood collected as part of PATHOS, will facilitate further empirical understanding of this new disease and its response to treatment.

trial registrationThis study is registered with ClinicalTrials.gov identifier NCT02215265 .

Indexed as

Chemoradiotherapy, AdjuvantDeglutitionHumansNeck DissectionOral Surgical ProceduresOropharyngeal NeoplasmsPapillomavirus InfectionsProspective StudiesQuality of LifeRadiation DosageRadiotherapy, AdjuvantSurvival AnalysisTreatment Outcome

Identifiers

PMID26311526
PMCPMC4549836
OpenAlexW2141898515

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.