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
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
Affiliations
Philipp Reinhardt
Department of Radiation Oncology, Bern University Hospital and University of Bern, Inselspital
Roland Giger
Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Bern University Hospital and University of Bern, Inselspital
Eberhard Seifert
Division of Phoniatrics, Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Bern University Hospital and University of Bern, Inselspital
Mohamed Shelan
Department of Radiation Oncology, Bern University Hospital and University of Bern, Inselspital
Elena Riggenbach
Department of Radiation Oncology, Bern University Hospital and University of Bern, Inselspital
Dario Terribilini
Division of Medical Radiation Physics and Department of Radiation Oncology, Inselspital, Bern University Hospital and University of Bern
Andreas Joosten
Division of Medical Radiation Physics and Department of Radiation Oncology, Inselspital, Bern University Hospital and University of Bern
Daniel H. Schanne
Department of Radiation Oncology, Bern University Hospital and University of Bern, Inselspital
Daniel M. Aebersold
Department of Radiation Oncology, Bern University Hospital and University of Bern, Inselspital
Peter Manser
Division of Medical Radiation Physics and Department of Radiation Oncology, Inselspital, Bern University Hospital and University of Bern
Matthias S. Dettmer
Department of Pathology, Klinikum Stuttgart
Christian Simon
Department of Otolaryngology - Head and Neck Surgery, CHUV University of Lausanne
Esat M. Ozsahin
Department of Radiation Oncology, Lausanne University Hospital and Lausanne University
Raphaël Moeckli
Institut of Radiation Physics, Lausanne University Hospital and Lausanne University
Andreas Limacher
Clinical Trials Unit Bern, University of Bern
Francesca Caparrotti
Department of Radiation Oncology, Genève University Hospital
Deepa Nair
Department of Head Neck Surgical Oncology, ACTREC, Tata Memorial Centre, Homi Bhabha National Institute
Jean Bourhis
Department of Radiation Oncology, Lausanne University Hospital and Lausanne University
Martina A. Broglie
Department of Head and Neck Surgery, University Hospital of Zurich
Abrahim Al-Mamgani
Department of Radiation Oncology, Netherlands Cancer Institute/Antoni van Leeuwenhoek
Olgun Elicin
Department of Radiation Oncology, Bern University Hospital and University of Bern, Inselspital
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
