Actively Recruiting
VoiceS: Voice Quality After Transoral CO2-Laser Surgery Versus Single Vocal Cord Irradiation for Larynx Cancer
Led by Olgun Elicin · Updated on 2025-10-07
34
Participants Needed
4
Research Sites
575 weeks
Total Duration
On this page
Sponsors
O
Olgun Elicin
Lead Sponsor
U
University of Bern
Collaborating Sponsor
AI-Summary
What this Trial Is About
Laser surgery and radiotherapy are well-established standards of care for unilateral stage 0 \& I carcinoma in situ (Cais) and squamous cell carcinoma of glottic larynx (SCCGL). Based on meta-analyses, functional and oncological outcome after both treatment modalities are comparable1-5. However, no properly conducted randomized trials comparing these treatments exist. The only such trial with the endpoint of voice quality had to be prematurely closed due to low accrual6. The traditional radiotherapy involves the treatment of the whole larynx. Recently, a new radiotherapy technique was introduced by a team of researchers from Netherlands, where the treated target volume consists of involved vocal cord and therefore 8 to 10-fold smaller than the target volumes used for traditional whole larynx irradiation. The treatment is reduced to 16 fractions which corresponds to 3 weeks and a day7-12. The results of a prospective cohort (n=30) with single vocal cord irradiation (SVCI) were compared with the results of a historical prospective cohort previously treated with whole larynx radiotherapy (n=131) in the same institute. The median follow-up was 30 months. The voice handicap index (VHI) at all time points beginning from the 6th week after SVCI was significantly superior to the same time points with conventional radiotherapy. Moreover, a comparable local control with SVCI (100%) vs. conventional radiotherapy (92%) was reported at two years, p=0.2412. Based on this information, the investigators' main aim is to compare SVCI to Transoral CO2-Laser Microsurgical Cordectomy (TLM) with the main focus of patient-reported voice quality.
CONDITIONS
Official Title
VoiceS: Voice Quality After Transoral CO2-Laser Surgery Versus Single Vocal Cord Irradiation for Larynx Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status 0-1 at the time of registration
- 18 years of age or older
- Baseline voice quality assessments documented by VHI, JS, RBH, GNE, SPR
- Histologically confirmed, previously untreated unilateral stage 0 or I glottic larynx cancer
- History and physical exam by head and neck surgeon and radiation oncologist within 28 days prior to registration
- Expected to tolerate both study treatments
- Panendoscopy performed confirming feasibility of transoral exposure for resection
- Tumor location allows resection with at least 2 mm margin without involvement of contralateral vocal fold, arytenoid cartilage, or thyroid cartilage (Cordectomy Type I-IV)
- Hemoglobin level of at least 10 g/dL within 28 days prior to enrollment (transfusion allowed to achieve this)
- Women of child-bearing potential use effective contraception and have negative pregnancy test within 28 days prior to enrollment; agree not to become pregnant during study and 30 days after radiotherapy; men agree not to father a child during this time
- Signed informed consent obtained
You will not qualify if you...
- Infection affecting voice quality at time of voice assessment
- Tumor involving the anterior commissure
- Previous curative oncologic surgery or radiotherapy to the larynx (except certain biopsy cases)
- Synchronous or prior malignancies except certain treated skin cancers, cervical carcinoma in situ, low-risk prostate or breast cancer with cancer-free interval as specified
- Co-existing disease limiting survival to less than 6 months
- Active bacterial or fungal infection requiring intravenous antibiotics at registration
- History of voice disorders unrelated to current cancer lasting longer than 3 weeks
- Illness requiring hospitalization or preventing study therapy within 28 days before registration
- Psychological, familial, social, or geographical issues potentially interfering with study compliance or follow-up schedule, as discussed prior to registration
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Institut Gustave Roussy
Paris, France, 94805
Actively Recruiting
2
Tata Memorial Hospital Mumbai
Mumbai, Maharashtra, India, 400012
Actively Recruiting
3
Inselspital, Bern University Hospital
Bern, Canton of Bern, Switzerland, 3010
Actively Recruiting
4
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8091
Actively Recruiting
Research Team
O
Olgun Elicin, M.D.
CONTACT
T
Timo Nannen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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