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.