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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Focal radiotherapy limited to the involved vocal cord(s) plus additional margins accounting for respiration and set-up errors.
Radiotherapy to the entire larynx, with target volumes defined to lead to traditional volumes from conventional complete larynx radiotherapy.
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
London Health Sciences Centre
London, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Local control
Local control rate of vocal-cord radiotherapy
Time frame: At 2-year follow-up
Voice Handicap Index-10 score
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.
Time frame: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up
MD Anderson Dysphagia Inventory score
Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life.
Time frame: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up
MD Anderson Symptom Inventory-Head & Neck score
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.
Time frame: 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)
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.
Time frame: Week 0 post-treatment and at 6-month follow-up
Rates of acute toxicity as per CTCAE v5.0
Time frame: Week 0 post-treatment and at 2-month follow-up
Rates of chronic toxicity as per CTCAE v5.0
Time frame: At 6-month, 1-year, 2-year and 5-year post-treatment
Rates of new hypothyroidism
Time frame: At 2- and 5-year follow-up
Rates of cerebrovascular event (transient ischemic attack or stroke)
Time frame: At 5-year follow-up
Overall survival
Time frame: At 2- and 5-year follow-up
Time to recurrence
Time frame: At 2- and 5-year follow-up
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