Evidence map›Paper›PMID 32795322›Full record

ArticleRadiation oncology (London, England)2020

Preservation of swallowing in resected oral cavity squamous cell carcinoma: examining radiation volume effects (PRESERVE): study protocol for a randomized phase II trial.

Pencilla Lang, Jessika Contreras, Noah Kalman, Claire Paterson, Houda Bahig, Astrid Billfalk-Kelly, Sinead Brennan, Kathy Rock, Nancy Read, Varagur Venkatesan and 13 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Radiation oncology (London, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03997643 (Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 33% 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.

NCT03997643 phase2recruitingnot on this map

Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects: A Randomized Trial

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2019 to 2026Enrolled90ConditionsHead and Neck CancerArmsRadiotherapy to all dissected areas, Omit radiation to pN0 neck
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
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

23 authors at 8 institutions in 4 countries.

Pencilla LangDivision of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada. pencilla.lang@lhsc.on.ca.ORCID http://orcid.org/0000-0003-3156-4450
Jessika ContrerasDepartment of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, Florida, USA.
Noah KalmanDepartment of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, Florida, USA.
Claire PatersonBeatson West of Scotland Cancer Centre, Glasgow, UK.
Houda BahigDepartment of Radiation Oncology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.
Astrid Billfalk-KellyDepartment of Radiation Oncology, Eastern Health, St. John's, Newfoundland, Canada.
Sinead BrennanSaint Luke's Radiation Oncology Network, Dublin, Ireland.
Kathy RockDepartment of Radiation Oncology, Cork University Hospital, Cork, Ireland.
Nancy ReadDivision of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.
Varagur VenkatesanDivision of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.
Jinka SathyaDivision of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.
Lucas C MendezDivision of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.
S Danielle MacNeilDepartment of Otolaryngology - Head and Neck Surgery, Western University, London, Ontario, Canada.
Anthony C NicholsDepartment of Otolaryngology - Head and Neck Surgery, Western University, London, Ontario, Canada.
Kevin FungDepartment of Otolaryngology - Head and Neck Surgery, Western University, London, Ontario, Canada.
Adrian MendezDepartment of Otolaryngology - Head and Neck Surgery, Western University, London, Ontario, Canada.
Eric WinquistDepartment of Medical Oncology, Western University, London, Ontario, Canada.
Sara KuruvillaDepartment of Medical Oncology, Western University, London, Ontario, Canada.
Paul StewartDepartment of Medical Oncology, Western University, London, Ontario, Canada.
Andrew WarnerDivision of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.
Sylvia MitchellDivision of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.
Julie A TheurerSchool of Communication Sciences and Disorders, Western University, London, Ontario, Canada.
David A PalmaDivision of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.
London Health Sciences Centre · CAWestern University · CABaptist Hospital of Miami · USBeatson West of Scotland Cancer Centre · GBCentre Hospitalier de l’Université de Montréal · CACork University Hospital · IESt. John’s Health Sciences Centre · CASt. Luke's Hospital · IE

Funding

CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
NCRR NIH HHS UL1 RR025780
6 · The paper itself

Abstract

backgroundPatients with resected oral cavity squamous cell carcinoma (OCSCC) are often treated with adjuvant radiation (RT) ± concomitant chemotherapy based on pathological findings. Standard RT volumes include all surgically dissected areas, including the tumour bed and dissected neck. RT has significant acute and long-term toxicities including odynophagia, dysphagia, dermatitis and fibrosis. The goal of this study is to assess the rate of regional failure with omission of radiation to the surgically dissected pathologically node negative (pN0) hemi-neck(s) compared to historical control, and to compare oncologic outcomes, toxicity, and quality of life (QoL) profiles between standard RT volumes and omission of RT to the pN0 neck.

methodsThis is a multicentre phase II study randomizing 90 patients with T1-4 N0-2 OCSCC with at least one pN0 hemi-neck in a 1:2 ratio between standard RT volumes and omission of RT to the pN0 hemi-neck(s). Patients will be stratified based on overall nodal status (nodal involvement vs. no nodal involvement) and use of concurrent chemotherapy. The primary endpoint is regional failure in the pN0 hemi-neck(s); we hypothesize that a 2-year regional recurrence of 20% or less will be achieved. Secondary endpoints include overall and progression-free survival, local recurrence, rate of salvage therapy, toxicity and QoL. DISCUSSION: This study will provide an assessment of omission of RT to the dissected pN0 hemi-neck(s) on oncologic outcomes, QoL and toxicity. Results will inform the design of future definitive phase III trials.

trial registrationClinicaltrials.gov identifier: NCT03997643 . Date of registration: June 25, 2019, Current version: 2.0 on July 11 2020.

Indexed as

AdolescentAdultAgedAged, 80 and overCanadaChemotherapy, AdjuvantClinical Trials, Phase II as TopicCombined Modality TherapyDeglutition DisordersFemaleHumansMaleMiddle AgedMulticenter Studies as TopicNeck DissectionNeoplasm Recurrence, LocalDe-escalationHead and neck cancerOral cavityQuality of lifeRadiotherapyRandomized controlled trialRecurrenceSurvival

Identifiers

PMID32795322
PMCPMC7427897
OpenAlexW3049706543

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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.