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

Phase 2

Recruiting

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group performance status 0-2

Stage T1a-b N0 of the true vocal cords planned for definitive RT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up

Awards & highlights

VOCAL Trial Summary

This trial is testing a new treatment for early stage cancer of the voice box.

Who is the study for?

This trial is for people with early-stage glottic cancer (T1N0) who can't have or don't want laser surgery. They should be in decent physical shape and not have had other cancers (except certain skin cancers) in the last 2 years, no prior radiation to the head and neck, and not be pregnant or breastfeeding.Check my eligibility

What is being tested?

The study compares two types of radiotherapy for early vocal cord cancer: one that targets only the vocal cords, and another that treats the entire larynx. It's a randomized trial where patients are put into groups by chance to see which method works best at controlling cancer without affecting voice quality.See study design

What are the potential side effects?

Potential side effects from both types of radiotherapy may include sore throat, difficulty swallowing, changes in voice quality, dry mouth, fatigue, skin irritation around the neck area. Long-term effects could involve permanent changes to voice or swallowing.

VOCAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My vocal cord cancer is in an early stage and I am planning to have radiation therapy.

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I cannot or have chosen not to undergo laser surgery.

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My cancer is confirmed as squamous cell carcinoma.

VOCAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Local control

Secondary outcome measures

Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)

MD Anderson Dysphagia Inventory score

MD Anderson Symptom Inventory-Head & Neck score

+7 more

VOCAL Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Vocal-cord RadiotherapyExperimental Treatment1 Intervention

Group II: Complete Larynx RadiotherapyActive Control1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterOTHER

2,977 Previous Clinical Trials

1,789,383 Total Patients Enrolled

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

368 Previous Clinical Trials

129,602 Total Patients Enrolled

London Health Sciences CentreOTHER

143 Previous Clinical Trials

49,807 Total Patients Enrolled

Media Library

Complete Larynx Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT03759431 — Phase 2

Neck Cancer Research Study Groups: Vocal-cord Radiotherapy, Complete Larynx Radiotherapy

Neck Cancer Clinical Trial 2023: Complete Larynx Radiotherapy Highlights & Side Effects. Trial Name: NCT03759431 — Phase 2

Complete Larynx Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03759431 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical trial still open?

"Currently, this research is seeking out subjects. It was initially published on October 11th 2018 and it's most recent update occurred November 11th 2022 - according to clinicaltrials.gov."

Answered by AI

What is the participant count for this clinical investigation?

"Correct. According to clinicaltrials.gov, this medical trial is currently enrolling participants; it was initially posted on October 11th 2018 and updated most recently on November 11th 2022. This study requires the recruitment of 155 patients from 3 different sites."

Answered by AI

Has the FDA granted authorization for Vocal-cord Radiotherapy?

"Our internal assessment at Power reveals that Vocal-cord Radiotherapy is rated 2 as this trial has yet to display efficacy but there are reports supporting its safety."

Answered by AI

Recent research and studies

BMC CancerJournal

Vocal-cord Only Vs. Complete Laryngeal Radiation (VOCAL): A Randomized Multicentric Bayesian Phase II Trial

Bahig, Houda, David I. Rosenthal, Félix-Phuc Nguyen-Tan, David C. Fuller, Ying Yuan, Katherine A. Hutcheson, Apostolos Christopoulos, et al.. 2021. “Vocal-cord Only Vs. Complete Laryngeal Radiation (VOCAL): A Randomized Multicentric Bayesian Phase II Trial”. BMC Cancer. Springer Science and Business Media LLC. doi:10.1186/s12885-021-08195-8.

clinicaltrials.govStudy

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

Houda Bahig 2018. "Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03759431.