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NCT03759431 · ClinicalTrials.gov registry record · Phase 2
Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer
A Phase 2 study of Larynx Cancer and Cancer Neck, sponsored by Centre hospitalier de l'Université de Montréal (CHUM).
- Active
- Registry status
- Phase 2
- Development phase
- 155
- Enrollment target
- 3
- Study locations
NCT03759431 is a Phase 2 study of Larynx Cancer and Cancer Neck that is active but no longer recruiting, run by Centre hospitalier de l'Université de Montréal (CHUM). The registered enrollment target is 155 participants, below the 326-participant average among 11 other Larynx Cancer trials with a reported enrollment target (52% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT03759431, a Phase 2 study of Larynx Cancer and Cancer Neck, is active but no longer recruiting, sponsored by Centre hospitalier de l'Université de Montréal (CHUM).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 155 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- RADIATION Vocal-cord Radiotherapy
- RADIATION Complete Larynx Radiotherapy
Study Locations (3)
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Ontario
- London Health Sciences Centre - London
Quebec
- Centre Hospitalier de l'Université de Montréal - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2018-10-11 |
| Est. Completion | 2026-12-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03759431
The ClinicalTrials.gov registry entry for NCT03759431 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 326-participant average among 11 other Larynx Cancer trials with a reported enrollment target (52% lower). The listed sponsor is Centre hospitalier de l'Université de Montréal (CHUM), which has 10 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Larynx Cancer appearing as the primary indexed condition, and to 2 interventions - of which Vocal-cord Radiotherapy is the first listed.
NCT03759431 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Texas, Ontario, Quebec.
Frequently Asked Questions
What is clinical trial NCT03759431 about?
NCT03759431 is a clinical study titled "Vocal-cord 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 co...
What is the current status of trial NCT03759431?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 155 participants. The study started on 2018-10-11. Estimated completion is 2026-12-12.
What conditions does trial NCT03759431 study?
This clinical trial studies the following conditions: Larynx Cancer, Cancer Neck, Glottis Tumor.
What interventions are being tested in trial NCT03759431?
The interventions under investigation include: Vocal-cord Radiotherapy (RADIATION), Complete Larynx Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT03759431?
This trial is sponsored by Centre hospitalier de l'Université de Montréal (CHUM), which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03759431 being conducted?
This trial has 3 study locations across Texas, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.