NCT03759431

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (estimated)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cancer Neck
• Larynx Cancer
• Glottis Tumor

Interventions

Type	Name	Description
RADIATION	Vocal-cord Radiotherapy	Focal radiotherapy limited to the involved vocal cord(s) plus additional margins accounting for respiration and set-up errors.
RADIATION	Complete Larynx Radiotherapy	Radiotherapy to the entire larynx, with target volumes defined to lead to traditional volumes from conventional complete larynx radiotherapy.

Timeline

• Start date: 2018-10-11
• Primary completion: 2026-12-12
• Completion: 2026-12-12
• First posted: 2018-11-30
• Last updated: 2025-03-21

Locations

3 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study