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

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase: Active, not recruiting; Phase 2

Conditions: Cancer Neck; Larynx Cancer; Glottis Tumor

Treatments: Radiation: Complete Larynx Radiotherapy; Radiation: Vocal-cord Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03759431

18.135

Details and patient eligibility

About

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.

Enrollment: 155 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 2 patient groups

Vocal-cord Radiotherapy

Experimental group

Treatment:

Radiation: Vocal-cord Radiotherapy

Complete Larynx Radiotherapy

Active Comparator group

Treatment:

Radiation: Complete Larynx Radiotherapy