Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer

This is a multicentrer, randomized Bayesian Phase II trial for patients with early stage (T1N0) glottic squamous cell carcinoma treated with radical radiotherapy. The primary objective is to assess the non-inferiority of local control achieved with vocal-cord only radiotherapy (VC-RT) compared to complete larynx radiotherapy (CL-RT) in T1N0 glottic laryngeal squamous cell cancer, measured at 2-years after treatment. Secondary outcomes include overall survival, as well as voice impairment, dysphagia and quality of life, measured respectively by the voice handicap index -10 (VHI-10), the MD Anderson Dysphagia Inventory (MDADI) and the MD Anderson Symptom Inventory- Head and Neck module (MDASI-HN). Patients will be randomized in a 1:3 ratio to CL-RT (39 patients) and VC-RT (116 patients) arms. There will be stratification by tumor stage (T1a/T1b) and by institution. An interim analysis is planned after the first 55 patients enrolled on the experimental arm have a 6-month follow-up.

NCT Number	NCT03759431
Lead Sponsor	Centre hospitalier de l'Université de Montréal (CHUM) Collaborators: London Health Sciences Centre, M.D. Anderson Cancer Center
Conditions	Cancer Neck, Larynx Cancer, Glottis Tumor
Enrollment	155 participants
Start Date	2018-10-11
Primary Completion	2026-12-12 (estimated)
Study Completion	2026-12-12 (estimated)
Updated on ClinicalTrials.gov	2025-03-21