MedTrace Logo

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

NCT03759431 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2025-03-21

No results posted yet for this 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

  • Cancer Neck
  • Larynx Cancer
  • Glottis Tumor

Interventions

RADIATION

Vocal-cord Radiotherapy

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

RADIATION

Complete Larynx Radiotherapy

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

Sponsors & Collaborators

  • London Health Sciences Centre

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Houda Bahig · Centre hospitalier de l'Université de Montréal (CHUM)

  • David Palma · London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-11
Primary Completion
2026-12-12
Completion
2026-12-12
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03759431 on ClinicalTrials.gov