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 [study protocol].

Reinhardt, Philipp; Giger, Roland; Seifert, Eberhard; Shelan, Mohamed; Riggenbach, Elena; Terribilini, Dario; Joosten, Andreas; Schanne, Daniel H; Aebersold, Daniel M; Manser, Peter; Dettmer, Matthias S; Simon, Christian; Ozsahin, Esat M; Moeckli, Raphaël; Limacher, Andreas; Caparrotti, Francesca; Nair, Deepa; Bourhis, Jean; Broglie, Martina A; Al-Mamgani, Abrahim; ... (2022). 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 [study protocol]. Trials, 23(1), p. 906. BioMed Central 10.1186/s13063-022-06841-5

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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.

Item Type:

Journal Article (Further Contribution)

Division/Institute:

04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Radiation Oncology
04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern
04 Faculty of Medicine > Service Sector > Institute of Pathology
04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Radiation Oncology > Medical Radiation Physics
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Ear, Nose and Throat Disorders (ENT)

UniBE Contributor:

Reinhardt, Philipp; Giger, Roland; Seifert, Eberhard; Shelan, Mohamed; Riggenbach, Elena; Terribilini, Dario; Joosten, Andreas; Schanne, Daniel Hendrik; Aebersold, Daniel Matthias; Manser, Peter; Dettmer, Matthias; Limacher, Andreas and Eliçin, Olgun

Subjects:

600 Technology > 610 Medicine & health
500 Science > 570 Life sciences; biology
500 Science > 530 Physics

ISSN:

1745-6215

Publisher:

BioMed Central

Funders:

[193] Swiss Cancer League = Krebsliga Schweiz

Language:

English

Submitter:

Pubmed Import

Date Deposited:

31 Oct 2022 11:36

Last Modified:

05 Dec 2022 16:27

Publisher DOI:

10.1186/s13063-022-06841-5

PubMed ID:

36303192

Uncontrolled Keywords:

Glottic cancer Larynx Radiotherapy Randomized controlled trial Transoral CO2-laser surgery Vocal cord irradiation

BORIS DOI:

10.48350/174256

URI:

https://boris.unibe.ch/id/eprint/174256

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