Actively Recruiting
Led by Olgun Elicin · Updated on 2025-10-07
34
Participants Needed
4
Research Sites
156 weeks
Total Duration
O
Olgun Elicin
Lead Sponsor
U
University of Bern
Collaborating Sponsor
Researchers are comparing two well-established treatments for early-stage unilateral glottic larynx cancer, specifically stage 0 and I squamous cell carcinoma: Transoral CO2-Laser Microsurgical Cordectomy (TLM) and a newer radiotherapy technique called Single Vocal Cord Irradiation (SVCI). Both treatments aim to control the cancer while preserving voice quality and larynx function. Previous studies suggest similar cancer control outcomes, but no randomized trial has directly compared the two treatments focusing on patient-reported voice quality. Participants will be randomly assigned to receive either TLM surgery using a CO2 laser or SVCI, which delivers radiation targeted only to the affected vocal cord in 16 treatment sessions over about three weeks. The surgery is typically done within three weeks after randomization, and both treatments are considered standard methods. The study does not involve blinding due to the nature of the treatments. The main goal is to assess voice quality after these treatments. During the study, participants will have their voice quality measured through patient-reported Voice Handicap Index (VHI) scores and objective voice tests at 6, 12, 18, and 24 months. Researchers will also monitor cancer control, treatment side effects, and toxicity up to five years. Regular assessments include clinical examinations and voice evaluations. The study aims to enroll adults 18 years or older with unilateral early-stage glottic cancer who are eligible for both treatments and able to comply with the follow-up schedule.
CONDITIONS
VoiceS: Voice Quality After Transoral CO2-Laser Surgery Versus Single Vocal Cord Irradiation for Larynx Cancer
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks for surgery or about 3 weeks for radiation
Participants receive one of two treatments: Transoral CO2-Laser Microsurgical Cordectomy (TLM), which is surgery performed within 3 weeks after randomization, or Single Vocal Cord Irradiation (SVCI) consisting of 16 radiation fractions over about 3 weeks.
1 surgical procedure or 16 radiation visits over 3 weeks
Duration - Up to 5 years
Participants are monitored for voice quality, disease control, and treatment toxicity with assessments at multiple time points up to 5 years after treatment.
Assessments at 6, 12, 18, 24 months and every 3 to 6 months up to 5 years
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
O
Olgun Elicin, M.D.
T
Timo Nannen
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Philipp Reinhardt, Roland Giger, Eberhard Seifert...
https://pubmed.ncbi.nlm.nih.gov/36303192