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 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, radiother...
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BMC
2022-10-01
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| Online Access: | https://doi.org/10.1186/s13063-022-06841-5 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Philipp Reinhardt |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-04-12T17:54:04Z |
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| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T17:54:04Z |
| publishDate | 2022-10-01 |
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| spelling | doaj.art-c6d49bb71dd34c73a1dabbe5d182a4442022-12-22T03:22:25ZengBMCTrials1745-62152022-10-0123111310.1186/s13063-022-06841-5VoiceS: 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 trialPhilipp Reinhardt0Roland Giger1Eberhard Seifert2Mohamed Shelan3Elena Riggenbach4Dario Terribilini5Andreas Joosten6Daniel H. Schanne7Daniel M. Aebersold8Peter Manser9Matthias S. Dettmer10Christian Simon11Esat M. Ozsahin12Raphaël Moeckli13Andreas Limacher14Francesca Caparrotti15Deepa Nair16Jean Bourhis17Martina A. Broglie18Abrahim Al-Mamgani19Olgun Elicin20Department of Radiation Oncology, Bern University Hospital and University of Bern, InselspitalDepartment of Oto-Rhino-Laryngology, Head and Neck Surgery, Bern University Hospital and University of Bern, InselspitalDivision of Phoniatrics, Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Bern University Hospital and University of Bern, InselspitalDepartment of Radiation Oncology, Bern University Hospital and University of Bern, InselspitalDepartment of Radiation Oncology, Bern University Hospital and University of Bern, InselspitalDivision of Medical Radiation Physics and Department of Radiation Oncology, Inselspital, Bern University Hospital and University of BernDivision of Medical Radiation Physics and Department of Radiation Oncology, Inselspital, Bern University Hospital and University of BernDepartment of Radiation Oncology, Bern University Hospital and University of Bern, InselspitalDepartment of Radiation Oncology, Bern University Hospital and University of Bern, InselspitalDivision of Medical Radiation Physics and Department of Radiation Oncology, Inselspital, Bern University Hospital and University of BernDepartment of Pathology, Klinikum StuttgartDepartment of Otolaryngology - Head and Neck Surgery, CHUV University of LausanneDepartment of Radiation Oncology, Lausanne University Hospital and Lausanne UniversityInstitut of Radiation Physics, Lausanne University Hospital and Lausanne UniversityClinical Trials Unit Bern, University of BernDepartment of Radiation Oncology, Genève University HospitalDepartment of Head Neck Surgical Oncology, ACTREC, Tata Memorial Centre, Homi Bhabha National InstituteDepartment of Radiation Oncology, Lausanne University Hospital and Lausanne UniversityDepartment of Head and Neck Surgery, University Hospital of ZurichDepartment of Radiation Oncology, Netherlands Cancer Institute/Antoni van LeeuwenhoekDepartment of Radiation Oncology, Bern University Hospital and University of Bern, InselspitalAbstract 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 2019-01506https://doi.org/10.1186/s13063-022-06841-5Glottic cancerLarynxRadiotherapyVocal cord irradiationTransoral CO2-laser surgeryRandomized controlled trial |
| spellingShingle | 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 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 Trials Glottic cancer Larynx Radiotherapy Vocal cord irradiation Transoral CO2-laser surgery Randomized controlled trial |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Glottic cancer Larynx Radiotherapy Vocal cord irradiation Transoral CO2-laser surgery Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-022-06841-5 |
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