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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: Active Phase 2 study of Larynx Cancer and Cancer Neck, sponsored by Centre hospitalier de l'Université de Montréal (CHUM).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Local control rate of vocal-cord radiotherapy
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 |
What the registry record for NCT03759431 still lists
NCT03759431 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, below the 326-participant average among 11 other Larynx Cancer trials with a reported enrollment target (52% lower).
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 a single indexed study location in 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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