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Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer
NCT03759431 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centre hospitalier de l'Université de Montréal (CHUM), which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03759431 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Texas, Ontario, Quebec. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03759431?
The interventions under investigation include: Vocal-cord Radiotherapy (RADIATION), Complete Larynx Radiotherapy (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03759431?
This trial is sponsored by Centre hospitalier de l'Université de Montréal (CHUM), which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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