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

December 11, 2023 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

A Randomized Study of Vocal-cord Only 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

155

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • David Palma
    • Quebec
      • Montreal, Quebec, Canada, H2X 1R6
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal
        • Contact:
        • Principal Investigator:
          • Houda Bahig
        • Sub-Investigator:
          • Phuc-Félix Nguyen-Tan
  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • David I Rosenthal
        • Sub-Investigator:
          • Clifton D Fuller

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local control
Time Frame: At 2-year follow-up
Local control rate of vocal-cord radiotherapy
At 2-year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voice Handicap Index-10 score
Time Frame: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up
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
MD Anderson Dysphagia Inventory score
Time Frame: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up
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
MD Anderson Symptom Inventory-Head & Neck score
Time Frame: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up
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
Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Time Frame: Week 0 post-treatment and at 6-month follow-up
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
Rates of acute toxicity as per CTCAE v5.0
Time Frame: Week 0 post-treatment and at 2-month follow-up
Week 0 post-treatment and at 2-month follow-up
Rates of chronic toxicity as per CTCAE v5.0
Time Frame: At 6-month, 1-year, 2-year and 5-year post-treatment
At 6-month, 1-year, 2-year and 5-year post-treatment
Rates of new hypothyroidism
Time Frame: At 2- and 5-year follow-up
At 2- and 5-year follow-up
Rates of cerebrovascular event (transient ischemic attack or stroke)
Time Frame: At 5-year follow-up
At 5-year follow-up
Overall survival
Time Frame: At 2- and 5-year follow-up
At 2- and 5-year follow-up
Time to recurrence
Time Frame: At 2- and 5-year follow-up
At 2- and 5-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

M.D. Anderson Cancer Center
London Health Sciences Centre

Investigators

  • Study Chair: Houda Bahig, Centre hospitalier de l'Université de Montréal (CHUM)
  • Study Chair: David Palma, London Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2018

Primary Completion (Estimated)

June 12, 2024

Study Completion (Estimated)

July 12, 2026

Study Registration Dates

First Submitted

November 10, 2018

First Submitted That Met QC Criteria

November 28, 2018

First Posted (Actual)

November 30, 2018

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18.135

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Larynx Cancer

Clinical Trials on Vocal-cord Radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe