Cancer Neck, Glottis Tumor, Larynx Cancer
Conditions
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.
Interventions
RADIATIONVocal-cord Radiotherapy
Focal radiotherapy limited to the involved vocal cord(s) plus additional margins accounting for respiration and set-up errors.
RADIATIONComplete Larynx Radiotherapy
Radiotherapy to the entire larynx, with target volumes defined to lead to traditional volumes from conventional complete larynx radiotherapy.
Sponsors
London Health Sciences Centre
M.D. Anderson Cancer Center
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local control | At 2-year follow-up | Local control rate of vocal-cord radiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MD Anderson Dysphagia Inventory score | 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. |
| MD Anderson Symptom Inventory-Head & Neck score | 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. |
| Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) | 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. |
| Rates of acute toxicity as per CTCAE v5.0 | Week 0 post-treatment and at 2-month follow-up | — |
| Voice Handicap Index-10 score | 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. |
| Rates of new hypothyroidism | At 2- and 5-year follow-up | — |
| Rates of cerebrovascular event (transient ischemic attack or stroke) | At 5-year follow-up | — |
| Overall survival | At 2- and 5-year follow-up | — |
| Time to recurrence | At 2- and 5-year follow-up | — |
| Rates of chronic toxicity as per CTCAE v5.0 | At 6-month, 1-year, 2-year and 5-year post-treatment | — |
Countries
Canada, United States
Outcome results
None listed