Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials ID:NCT03759431
This Phase II trial compares vocal-cord only radiotherapy to complete larynx radiotherapy in patients with T1N0 glottic squamous cell carcinoma. Eligible participants have biopsy-confirmed carcinoma, ECOG status 0-2, and are unsuitable for or declined laser surgery. Interventions include focal radiotherapy for vocal cords and full larynx radiotherapy.
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Program Overview
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.
Eligibility Criteria
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.
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