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

NCT03759431 | Active Not Recruiting Phase 2 FDA Device

• 1 other identifier: 18.135
• Study Type: interventional
• Target: 155
• Locations: 2 countries
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Local control

  Local control rate of vocal-cord radiotherapy

  At 2-year follow-up

Secondary Outcomes (10)

• Voice Handicap Index-10 score

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

• MD Anderson Dysphagia Inventory score

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

• MD Anderson Symptom Inventory-Head & Neck score

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

• Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)

  Week 0 post-treatment and at 6-month follow-up

• Rates of acute toxicity as per CTCAE v5.0

  Week 0 post-treatment and at 2-month follow-up

Study Arms (2)

Vocal-cord Radiotherapy

EXPERIMENTAL

Radiation: Vocal-cord Radiotherapy

Complete Larynx Radiotherapy

ACTIVE COMPARATOR

Radiation: Complete Larynx Radiotherapy

Interventions

Vocal-cord Radiotherapy RADIATION

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

Vocal-cord Radiotherapy

Complete Larynx Radiotherapy RADIATION

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

Complete Larynx Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• London Health Sciences Centre: collaborator
• M.D. Anderson Cancer Center: collaborator

Study Sites (3)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 1R6, Canada

Location

Related Publications (1)

• Bahig H, Rosenthal DI, Nguyen-Tan FP, Fuller DC, Yuan Y, Hutcheson KA, Christopoulos A, Nichols AC, Fung K, Ballivy O, Filion E, Ng SP, Lambert L, Dorth J, Hu KS, Palma D. Vocal-cord Only vs. Complete Laryngeal radiation (VOCAL): a randomized multicentric Bayesian phase II trial. BMC Cancer. 2021 Apr 22;21(1):446. doi: 10.1186/s12885-021-08195-8.

  PMID: 33888069 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Officials

• Houda Bahig

  Centre hospitalier de l'Université de Montréal (CHUM)

  STUDY CHAIR

• David Palma

  London Health Sciences Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized

Study Record Dates

• First Submitted: November 10, 2018
• First Posted: November 30, 2018
• Study Start: October 11, 2018
• Primary Completion (Estimated): December 12, 2026
• Study Completion (Estimated): December 12, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

US (1); CA (2)