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

Study acronym: VOCAL
StatusActive, Not Recruiting
PhasePhase 2
Started2018-10-11
View on ClinicalTrials.gov ↗

Amendment history

2025-03-18
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-10-12→2026-12-12
Completion date2026-07-12→2026-12-12
Study sitesdetails revised at 3 of 3 sites
2024-09-23
Study Status v6
Primary completion date2024-06-12→2024-10-12
2023-12-11
Study Status v5
Primary completion date2024-12-12→2024-06-12
Completion date2024-12-12→2026-07-12
2022-11-11
Study Status, Sponsor/Collaborators v4
Re-verified, no change to tracked fields
2021-02-19
Study Status, Contacts/Locations v3
Study sitesdetails revised at 2 of 3 sites
Show 2 earlier versions
2020-04-13
Study Status v2
Re-verified, no change to tracked fields
2018-11-30
Study Identification, Study Status v1
Study title-22 characters
Vocal-cord vs. Complete LarynxLaryngeal Radiotherapy Afor RandomizedEarly MulticentricGlottic Bayesian Phase II TrialCancer
2018-11-28
Original filing
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.
Trial Details
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