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

Larynx Cancer Clinical Trial

— VOCAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03759431
• Other study ID #: 18.135
• Status: Recruiting
• Phase: Phase 2
• Start date: October 11, 2018
• Est. completion date: July 12, 2026

Study information

• Verified date: December 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Diane Trudel
• Phone: 514-890-8000
• Email: diane.dt.trudel.chum[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: July 12, 2026
• Est. primary completion date: June 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stage T1a-b N0 of the true vocal cords planned for definitive RT
• Patient not candidate for laser surgery or declined laser surgery
• Biopsy-confirmed squamous cell carcinoma, including verrucous carcinoma
• Eastern Cooperative Oncology Group performance status 0-2
• Ability to provide written informed consent.

Exclusion Criteria:

• Previous irradiation of the head and neck (HNC) region
• Pregnancy or breastfeeding
• Any medical condition that represents, in the opinion of the investigator, a contraindication to radiotherapy or would prevent follow-up after radiotherapy.
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years.

Related Conditions & MeSH terms

• Cancer Neck
• Glottis Tumor
• Laryngeal Neoplasms
• Larynx Cancer

Intervention

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

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	Centre Hospitalier de l'Université de Montréal	Montreal	Quebec
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	London Health Sciences Centre, M.D. Anderson Cancer Center

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control	Local control rate of vocal-cord radiotherapy	At 2-year follow-up
Secondary	Voice Handicap Index-10 score	Scores are rated on a 0-4 scale to indicate the presence and severity of the symptoms. Lower scores represent better functioning and quality of life.	Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up
Secondary	MD Anderson Dysphagia Inventory score	Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life.	Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up
Secondary	MD Anderson Symptom Inventory-Head & Neck score	The core and head and neck cancer specific symptoms are rated on a 0-10 scale to indicate the presence and severity of the symptoms. Lower scores represent better functioning and quality of life.	Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up
Secondary	Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)	The attributes of CAPE-V are: (a) Overall Severity; (b) Roughness; (c) Breathiness; (d) Strain; (e) Pitch; and (f) Loudness. Each attribute is displayed accompanied by a 100- millimeter line forming a visual analog scale, with a higher score representing more deviant voice attributes.	Week 0 post-treatment and at 6-month follow-up
Secondary	Rates of acute toxicity as per CTCAE v5.0		Week 0 post-treatment and at 2-month follow-up
Secondary	Rates of chronic toxicity as per CTCAE v5.0		At 6-month, 1-year, 2-year and 5-year post-treatment
Secondary	Rates of new hypothyroidism		At 2- and 5-year follow-up
Secondary	Rates of cerebrovascular event (transient ischemic attack or stroke)		At 5-year follow-up
Secondary	Overall survival		At 2- and 5-year follow-up
Secondary	Time to recurrence		At 2- and 5-year follow-up