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Open Access 01-12-2021 | Radiotherapy | Study protocol

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

Authors: 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, Edith Filion, Sweet Ping Ng, Louise Lambert, Jennifer Dorth, Kenneth S. Hu, David Palma

Published in: BMC Cancer | Issue 1/2021

Abstract

Background

Radiotherapy, 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.

Methods

One 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 registration

ClinicalTrials.gov Identifier: NCT03759431

Registration date: November 30, 2018

Available only for authorised users

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Title: Vocal-cord Only vs. Complete Laryngeal radiation (VOCAL): a randomized multicentric Bayesian phase II trial
Authors: 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
Edith Filion
Sweet Ping Ng
Louise Lambert
Jennifer Dorth
Kenneth S. Hu
David Palma
Publication date: 01-12-2021
Publisher: BioMed Central
Keyword: Radiotherapy
Published in: BMC Cancer / Issue 1/2021
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-021-08195-8

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