Evidence map›Paper›PMID 33888069›Full record

Trial reportBMC cancer2021

Vocal-cord Only vs. Complete Laryngeal radiation (VOCAL): a randomized multicentric Bayesian phase II trial.

Houda Bahig, David I Rosenthal, Félix-Phuc Nguyen-Tan, David C Fuller, Ying Yuan, Katherine A Hutcheson, Apostolos Christopoulos, Anthony C Nichols, Kevin Fung, Olivier Ballivy and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03759431 (A Randomized Study of Vocal-cord Only vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.2field-weighted citation impact, top 22% 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.

NCT03759431 phase2active not recruitingnot on this map

A Randomized Study of Vocal-cord Only vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer

TypeinterventionalSponsorCentre hospitalier de l'Université de Montréal (CHUM)Ran2018 to 2026Enrolled155ConditionsCancer Neck, Larynx Cancer, Glottis TumorArmsVocal-cord Radiotherapy, Complete Larynx Radiotherapy
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
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  8. Review
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  10. COAmerican journal of translational research · 2023
    Article
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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

16 authors at 6 institutions in 3 countries.

Houda BahigRadiation Oncology Department, Centre Hospitalier de l'Université de Montréal, 1051 Sanguinet, Montreal, QC, H2X 3E4, Canada. Houda.bahig.chum@ssss.gouv.qc.ca.
David I RosenthalRadiation Oncology Department, University of Texas MD Anderson Cancer Center, 1515 Holcombe, Houston, TX, 77030, USA. dirosenthal@mdanderson.org.
Félix-Phuc Nguyen-TanRadiation Oncology Department, Centre Hospitalier de l'Université de Montréal, 1051 Sanguinet, Montreal, QC, H2X 3E4, Canada.
David C FullerRadiation Oncology Department, University of Texas MD Anderson Cancer Center, 1515 Holcombe, Houston, TX, 77030, USA.
Ying YuanBiostatistics Department, University of Texas MD Anderson Cancer Center, Houston, USA.
Katherine A HutchesonHead and Neck Surgery Department, University of Texas MD Anderson Cancer Center, Houston, USA.
Apostolos ChristopoulosHead and Neck Surgery Department, Centre Hospitalier de l'Université de Montréal, Montreal, 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.
Olivier BallivyRadiation Oncology Department, Centre Hospitalier de l'Université de Montréal, 1051 Sanguinet, Montreal, QC, H2X 3E4, Canada.
Edith FilionRadiation Oncology Department, Centre Hospitalier de l'Université de Montréal, 1051 Sanguinet, Montreal, QC, H2X 3E4, Canada.
Sweet Ping NgRadiation Oncology Department, Peter MacCallum Cancer Centre, Melbourne, Australia.
Louise LambertRadiation Oncology Department, Centre Intégré de Cancérologie de Laval, Laval, Canada.
Jennifer DorthRadiation Oncology Department, Case Western Reserve University, Cleveland, USA.
Kenneth S HuRadiation Oncology Department, NYU Langone Health, Newyork, USA.
David PalmaRadiation Oncology Department, Western University, London, Ontario, Canada.
Centre Hospitalier de l’Université de Montréal · CAThe University of Texas MD Anderson Cancer Center · USWestern University · CACase Western Reserve University · USCentre Integre de Sante et de Services Sociaux de Laval · CAPeter MacCallum Cancer Centre · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRadiotherapy, along with laser surgery, is considered a standard treatment option for patients with early glottic squamous cell cancer (SCC). Historically, patients have received complete larynx radiotherapy (CL-RT) due to fear of swallowing and respiratory laryngeal motion and this remains the standard approach in many academic institutions. Local control (LC) rates with CL-RT have been excellent, however this treatment can carry significant toxicities include adverse voice and swallowing outcomes, along with increased long-term risk of cerebrovascular morbidity. A recent retrospective study reported improved voice quality and similar local control outcomes with focused vocal cord radiotherapy (VC-RT) compared to CL-RT. There is currently no prospective evidence on the safety of VC-RT. The primary objective of this Bayesian Phase II trial is to compare the LC of VC-RT to that of CL-RT in patients with T1N0 glottic SCC.

methodsOne hundred and fifty-five patients with T1a-b N0 SCC of the true vocal cords that are n ot candidate or declined laser surgery, will be randomized in a 1:3 ratio the control arm (CL-RT) and the experimental arm (VC-RT). Randomisation will be stratified by tumor stage (T1a/T1b) and by site (each site will be allowed to select one preferred radiation dose regimen, to be used in both arms). CL-RT volumes will correspond to the conventional RT volumes, with the planning target volume extending from the top of thyroid cartilage lamina superiorly to the bottom of the cricoid inferiorly. VC-RT volumes will include the involved vocal cord(s) and a margin accounting for respiration and set-up uncertainty. The primary endpoint will be LC at 2-years, while secondary endpoints will include patient-reported outcomes (voice impairment, dysphagia and symptom burden), acute and late toxicity radiation-induced toxicity, overall survival, progression free survival, as well as an optional component of acoustic and objective measures of voice analysis using the Consensus Auditory-Perceptual Evaluation of Voice. DISCUSSION: This study would constitute the first prospective evidence on the efficacy and safety of VC-RT in early glottic cancer. If positive, this study would result in the adoption of VC-RT as standard approach in early glottic cancer.

trial registrationClinicalTrials.gov Identifier: NCT03759431 Registration date: November 30, 2018.

Indexed as

Bayes TheoremCarcinoma, Squamous CellFemaleGlottisHumansLarynxMagnetic Resonance ImagingMaleNeoplasm StagingRadiotherapyTomography, X-Ray ComputedTreatment OutcomeTumor BurdenVocal CordsGlottic cancerLarynxLocal controlRadiotherapyVocal cord

Identifiers

PMID33888069
PMCPMC8061218
OpenAlexW3153160897

What OpenQuestion holds

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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.