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NCT Number: NCT03759431

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 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.

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Key information

Conditions

Cancer Neck Glottis Tumor Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Larynx Cancer Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

London Health Sciences Centre, London, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stage T1a-b N0 of the true vocal cords planned for definitive RT
  • Patient not candidate for laser surgery or declined laser surgery
  • Biopsy-confirmed squamous cell carcinoma, including verrucous carcinoma
  • Eastern Cooperative Oncology Group performance status 0-2
  • Ability to provide written informed consent.

Exclusion criteria

  • Previous irradiation of the head and neck (HNC) region
  • Pregnancy or breastfeeding
  • Any medical condition that represents, in the opinion of the investigator, a contraindication to radiotherapy or would prevent follow-up after radiotherapy.
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years.

Treatment and study plan

Vocal-cord Radiotherapy

Radiation

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

Complete Larynx Radiotherapy

Radiation

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

Primary outcomes

  1. Local control

    Time frame: At 2-year follow-up

    Local control rate of vocal-cord radiotherapy

Secondary outcomes

  1. Voice Handicap Index-10 score

    Time frame: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up

    Scores are rated on a 0-4 scale to indicate the presence and severity of the symptoms. Lower scores represent better functioning and quality of life.

  2. MD Anderson Dysphagia Inventory score

    Time frame: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up

    Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life.

  3. MD Anderson Symptom Inventory-Head & Neck score

    Time frame: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up

    The core and head and neck cancer specific symptoms are rated on a 0-10 scale to indicate the presence and severity of the symptoms. Lower scores represent better functioning and quality of life.

  4. Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)

    Time frame: Week 0 post-treatment and at 6-month follow-up

    The attributes of CAPE-V are: (a) Overall Severity; (b) Roughness; (c) Breathiness; (d) Strain; (e) Pitch; and (f) Loudness. Each attribute is displayed accompanied by a 100- millimeter line forming a visual analog scale, with a higher score representing more deviant voice attributes.

  5. Rates of acute toxicity as per CTCAE v5.0

    Time frame: Week 0 post-treatment and at 2-month follow-up

  6. Rates of chronic toxicity as per CTCAE v5.0

    Time frame: At 6-month, 1-year, 2-year and 5-year post-treatment

  7. Rates of new hypothyroidism

    Time frame: At 2- and 5-year follow-up

  8. Rates of cerebrovascular event (transient ischemic attack or stroke)

    Time frame: At 5-year follow-up

  9. Overall survival

    Time frame: At 2- and 5-year follow-up

  10. Time to recurrence

    Time frame: At 2- and 5-year follow-up

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • London Health Sciences Centre
  • M.D. Anderson Cancer Center

Registry information

Official study title

A Randomized Study of Vocal-cord Only vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer

Acronym: VOCAL

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Nov 30, 2018
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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