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Open Access 01-12-2022 | CO2 Laser | Study protocol

VoiceS: voice quality after transoral CO₂ laser surgery versus single vocal cord irradiation for unilateral stage 0 and I glottic larynx cancer—a randomized phase III trial

Authors: Philipp Reinhardt, Roland Giger, Eberhard Seifert, Mohamed Shelan, Elena Riggenbach, Dario Terribilini, Andreas Joosten, Daniel H. Schanne, Daniel M. Aebersold, Peter Manser, Matthias S. Dettmer, Christian Simon, Esat M. Ozsahin, Raphaël Moeckli, Andreas Limacher, Francesca Caparrotti, Deepa Nair, Jean Bourhis, Martina A. Broglie, Abrahim Al-Mamgani, Olgun Elicin

Published in: Trials | Issue 1/2022

Abstract

Background

Surgery and radiotherapy are well-established standards of care for unilateral stage 0 and I early-stage glottic cancer (ESGC). Based on comparative studies and meta-analyses, functional and oncological outcomes after both treatment modalities are similar. Historically, radiotherapy (RT) has been performed by irradiation of the whole larynx. However, only the involved vocal cord is being treated with recently introduced hypofractionated concepts that result in 8 to 10-fold smaller target volumes. Retrospective data argues for an improvement in voice quality with non-inferior local control. Based on these findings, single vocal cord irradiation (SVCI) has been implemented as a routine approach in some institutions for ESGC in recent years. However, prospective data directly comparing SVCI with surgery is lacking. The aim of VoiceS is to fill this gap.

Methods

In this prospective randomized multi-center open-label phase III study with a superiority design, 34 patients with histopathologically confirmed, untreated, unilateral stage 0-I ESGC (unilateral cTis or cT1a) will be randomized to SVCI or transoral CO₂-laser microsurgical cordectomy (TLM). Average difference in voice quality, measured by using the voice handicap index (VHI) will be modeled over four time points (6, 12, 18, and 24 months). Primary endpoint of this study will be the patient-reported subjective voice quality between 6 to 24 months after randomization. Secondary endpoints will include perceptual impression of the voice via roughness – breathiness – hoarseness (RBH) assessment at the above-mentioned time points. Additionally, quantitative characteristics of voice, loco-regional tumor control at 2 and 5 years, and treatment toxicity at 2 and 5 years based on CTCAE v.5.0 will be reported.

Discussion

To our knowledge, VoiceS is the first randomized phase III trial comparing SVCI with TLM. Results of this study may lead to improved decision-making in the treatment of ESGC.

Trial registration

ClinicalTrials.gov NCT04057209. Registered on 15 August 2019. Cantonal Ethics Committee KEK-BE 2019-01506

Available only for authorised users

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Title: VoiceS: voice quality after transoral CO2 laser surgery versus single vocal cord irradiation for unilateral stage 0 and I glottic larynx cancer—a randomized phase III trial
Authors: Philipp Reinhardt
Roland Giger
Eberhard Seifert
Mohamed Shelan
Elena Riggenbach
Dario Terribilini
Andreas Joosten
Daniel H. Schanne
Daniel M. Aebersold
Peter Manser
Matthias S. Dettmer
Christian Simon
Esat M. Ozsahin
Raphaël Moeckli
Andreas Limacher
Francesca Caparrotti
Deepa Nair
Jean Bourhis
Martina A. Broglie
Abrahim Al-Mamgani
Olgun Elicin
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: CO2 Laser
Radiotherapy
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06841-5

Keynote webinar | Spotlight on medication adherence

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VoiceS: voice quality after transoral CO₂ laser surgery versus single vocal cord irradiation for unilateral stage 0 and I glottic larynx cancer—a randomized phase III trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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