Comparing voice quality after laser surgery and targeted radiotherapy for larynx cancer
VoiceS: Voice Quality After Transoral CO2-Laser Surgery Versus Single Vocal Cord Irradiation for Unilateral Stage 0 & I Glottic Larynx Cancer - A Randomized Phase III Trial
This study is testing whether laser surgery or targeted radiotherapy is better for preserving voice quality in patients with early-stage larynx cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Drugs / interventions | radiation |
| Locations | 4 sites (Paris and 3 other locations) |
| Trial ID | NCT04057209 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the voice quality outcomes of two treatment modalities for early-stage larynx cancer: Transoral CO2-Laser Microsurgical Cordectomy (TLM) and Single Vocal Cord Irradiation (SVCI). Both treatments are established standards of care, but no randomized trials have previously compared their effectiveness in preserving voice quality. The study will include patients with unilateral stage 0 or I glottic larynx cancer and will assess voice quality using validated measures. The trial is being conducted across multiple institutions in Switzerland.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histopathologically confirmed unilateral stage 0 or I glottic larynx cancer.
Not a fit: Patients with bilateral laryngeal cancer or those who cannot undergo the required surgical procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment for preserving voice quality in patients with early-stage larynx cancer.
How similar studies have performed: While there have been various studies on the individual treatments, this is one of the first randomized trials specifically comparing voice quality outcomes between these two approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. ECOG performance status 0-1 at the time of registration 2. ≥18 years of age 3. Baseline assessments and documentation of voice quality by means of VHI, JS, RBH, GNE, SPR 4. Histopathologically confirmed, previously untreated unilateral (cT1a or unilateral cTis) stage 0 or I glottic larynx cancer based on the UICC staging system (8th edition) 5. History and physical examination by treating physician (head and neck surgeon and radiation oncologist) within 28 days prior registration 6. The patient must be expected to withstand both study interventions 7. The patient must have undergone panendoscopy with assessment for the feasibility of transoral exposure for resection. Patients without feasible exposure are not eligible 8. Localization of the tumor should allow resection with a minimum of 2 mm macroscopical margin without extension to the contralateral vocal fold, without partial resection of the arytenoid cartilage and without resection of parts of thyroid cartilage (Cordectomy Type I-IV according the classification of the European Laryngological Society)13 9. Hemoglobin ≥10 g/dL or 6.2 mmol/L (Note: The use of transfusion to achieve Hgb ≥10 g/dL is acceptable) within the 28 days prior to accrual 10. Women with child-bearing potential and using effective contraception, and not pregnant and agree not to become pregnant (see section 8.6) during participation in the trial and 30 days after radiotherapy. A negative pregnancy test before inclusion (within 28 days) into the trial is required for all women with child-bearing potential. Men agree not to father a child during participation in the trial and 30 days after radiotherapy. 11. Written informed consent, signed by the patient and the investigator. Exclusion Criteria 1. Infection hampering the voice quality at the time of voice assessment 2. Involvement of the anterior commissure by the tumor 3. Previous oncologic surgery with curative intent (exception: excisional biopsies resulting in unacceptable close R0 or R1/R2 margins may be included) or radiotherapy to larynx 4. Synchronous or previous malignancies. Exceptions are adequately treated basal cell carcinoma or SCC of the skin, or in situ carcinoma of the cervix uteri, low-risk prostate cancer or breast with a cancer-free follow-up time of at least 3 years, or other previous malignancy with a progression-free interval of at least 5 years 5. Co-existing disease prejudicing survival (expected survival less than 6 months) 6. Active bacterial or fungal infection requiring intravenous antibiotics at the time of registration 7. History of any voice disorders (not related to the SCCGL) lasting longer than 3 weeks 8. Illness requiring hospitalization or precluding study therapy within 28 days before registration 9. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Where this trial is running
Paris and 3 other locations
- Institut Gustave Roussy — Paris, France (Recruiting)
- Tata Memorial Hospital Mumbai — Mumbai, Maharashtra, India (Recruiting)
- Inselspital, Bern University Hospital — Bern, Canton of Bern, Switzerland (Recruiting)
- University Hospital Zurich — Zurich, Canton of Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Olgun Elicin, M.D. — Inselspital, Bern University Hospital, 3010 Bern, Switzerland
- Study coordinator: Olgun Elicin, M.D.
- Email: olgun.elicin@insel.ch
- Phone: +41 31 632 26 32
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.