Study Comparing Vocal-Cord Only Radiotherapy to Complete Larynx Radiotherapy for Early Glottic Cancer

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

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03759431

Provider View

This clinical trial is exploring whether treating only the vocal cords with radiotherapy is as effective as treating the entire larynx in patients with early-stage glottic cancer. The study will also look at overall survival, voice changes, swallowing difficulties, and quality of life after treatment.

Patient Parameters

Program Overview

This study is testing two different radiotherapy approaches for patients with early-stage glottic cancer, which affects the vocal cords. The main goal is to see if focusing the treatment only on the vocal cords is as effective as treating the entire larynx in controlling the cancer two years after treatment. Researchers will also evaluate how these treatments affect patients' survival, voice quality, swallowing ability, and overall quality of life. Participants will be randomly assigned to receive either complete larynx radiotherapy or vocal-cord only radiotherapy. The study will include patients from multiple centers and will consider the stage of the tumor and the institution when assigning treatments. An early analysis will be conducted after some patients have been followed for six months.

Eligibility Criteria

Inclusion Criteria

  • Have early-stage (T1a-b N0) glottic cancer affecting the true vocal cords and are planned for radiotherapy.
  • Not suitable for or have declined laser surgery.
  • Have a biopsy-confirmed diagnosis of squamous cell carcinoma, including verrucous carcinoma.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Able to provide written informed consent to participate in the study.

Exclusion Criteria

  • Have had previous radiation treatment to the head and neck area.
  • Are pregnant or breastfeeding.
  • Have any medical condition that makes radiotherapy unsafe or would prevent follow-up after treatment, according to the investigator.
  • Have had another invasive cancer (except non-melanoma skin cancer) unless they have been disease-free for at least two years.

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