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| Name | Class |
|---|---|
| London Health Sciences Centre | OTHER |
| M.D. Anderson Cancer Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vocal-cord Radiotherapy | Experimental |
| |
| Complete Larynx Radiotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vocal-cord Radiotherapy | Radiation | Focal radiotherapy limited to the involved vocal cord(s) plus additional margins accounting for respiration and set-up errors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local control | Local control rate of vocal-cord radiotherapy | At 2-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up |
| MD Anderson Dysphagia Inventory score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Houda Bahig | Centre hospitalier de l'Université de Montréal (CHUM) | Study Chair |
| David Palma | London Health Sciences Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| London Health Sciences Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33888069 | Derived | 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. |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D007822 | Laryngeal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D007818 | Laryngeal Diseases |
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Randomized
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| Complete Larynx Radiotherapy | Radiation | Radiotherapy to the entire larynx, with target volumes defined to lead to traditional volumes from conventional complete larynx radiotherapy. |
|
Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life. |
| 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. | 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. | 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 |
| Rates of chronic toxicity as per CTCAE v5.0 | At 6-month, 1-year, 2-year and 5-year post-treatment |
| 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 |
| London |
| Ontario |
| N6A 5W9 |
| Canada |
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2X 1R6 | Canada |
| D012140 |
| Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |