AzTrials
AzTrials

Cancer NeckPhase 2VOCALNCT03759431

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

A Phase 2 study testing Vocal-cord Radiotherapy and Complete Larynx Radiotherapy in people with Cancer Neck and Larynx Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 3 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer Neck, Larynx Cancer, Glottis Tumor
What is being tested?
Vocal-cord Radiotherapy and Complete Larynx Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
3 sitesin 2 countries
Study dates
11 Oct 2018to 12 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Canada2 sites

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 1R6

Other trials in Canada

United States1 site

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: 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.

Being tested
Vocal-cord Radiotherapy, Complete Larynx Radiotherapy
Medical subject headings
Head and Neck Neoplasms, Laryngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vocal-cord RadiotherapyRadiation

    Focal radiotherapy limited to the involved vocal cord(s) plus additional margins accounting for respiration and set-up errors.

  • Complete Larynx RadiotherapyRadiation

    Radiotherapy to the entire larynx, with target volumes defined to lead to traditional volumes from conventional complete larynx radiotherapy.

Study groups in NCT03759431
Study groupRoleWhat they receive
Vocal-cord RadiotherapyExperimentalNot described
Receives: Radiation: Vocal-cord Radiotherapy
Complete Larynx RadiotherapyActive comparatorNot described
Receives: Radiation: Complete Larynx Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local control

    Local control rate of vocal-cord radiotherapy

    Measured: At 2-year follow-up

Secondary outcomes (10)

  1. 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.

    Measured: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up

  2. MD Anderson Dysphagia Inventory score

    Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life.

    Measured: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up

  3. 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.

    Measured: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up

  4. 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.

    Measured: Week 0 post-treatment and at 6-month follow-up

  5. Rates of acute toxicity as per CTCAE v5.0

    Measured: Week 0 post-treatment and at 2-month follow-up

  6. Rates of chronic toxicity as per CTCAE v5.0

    Measured: At 6-month, 1-year, 2-year and 5-year post-treatment

  7. Rates of new hypothyroidism

    Measured: At 2- and 5-year follow-up

  8. Rates of cerebrovascular event (transient ischemic attack or stroke)

    Measured: At 5-year follow-up

  9. Overall survival

    Measured: At 2- and 5-year follow-up

  10. Time to recurrence

    Measured: At 2- and 5-year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2018
  2. Study start11 Oct 2018
  3. Primary completion12 Dec 2026 (estimated)
  4. Study completion12 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized
Masking
None (open label)
Enrolment
155 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03759431
Sponsor's protocol ID
18.135
Acronym
VOCAL
Status last verified
Mar 2025
First submitted
10 Nov 2018
Last updated
21 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Bahig H, Rosenthal DI, Nguyen-Tan FP, Fuller DC, Yuan Y, Hutcheson KA, Christopoulos A, Nichols AC, Fung K, Ballivy O, Filion E, Ng SP, Lambert L, Dorth J, Hu KS, Palma D. Vocal-cord Only vs. Complete Laryngeal radiation (VOCAL): a randomized multicentric Bayesian phase II trial. BMC Cancer. 2021 Apr 22;21(1):446. doi: 10.1186/s12885-021-08195-8.

    PubMed 33888069

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vocal-cord Radiotherapy and Complete Larynx Radiotherapy in people with Cancer Neck and Larynx Cancer, run by Centre hospitalier de l'Université de Montréal (CHUM) at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local control (time frame: At 2-year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03759431, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in