Vocal-cord vs. Complete Laryngeal Radiation Therapy for Early Glottic Cancer

Official Title

A Randomized Study of Vocal-cord Only vs. Complete Laryngeal Radiation Therapy for Early Glottic Cancer

Summary:

This is a multicentre, randomized Bayesian Phase II trial for patients with early stage (T1N0) glottic squamous cell carcinoma treated with radical radiation therapy. The primary objective is to assess the non-inferiority of local control achieved with vocal-cord only radiation therapy (VC-RT) compared to complete larynx radiation therapy (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 tumour 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.

Trial Description

Primary Outcome:

• Local control

• Voice Handicap Index-10 score
• MD Anderson Dysphagia Inventory score
• MD Anderson Symptom Inventory-Head & Neck score
• Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
• Rates of acute toxicity as per CTCAE v5.0
• Rates of chronic toxicity as per CTCAE v5.0
• Rates of new hypothyroidism
• Rates of cerebrovascular event (transient ischemic attack or stroke)
• Overall survival
• Time to recurrence

View this trial on ClinicalTrials.gov