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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03759431
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : November 16, 2022
Sponsor:
Collaborators:
London Health Sciences Centre
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer Neck Larynx Cancer Glottis Tumor Radiation: Vocal-cord Radiotherapy Radiation: Complete Larynx Radiotherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study of Vocal-cord Only vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : December 12, 2024
Estimated Study Completion Date : December 12, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Vocal-cord Radiotherapy Radiation: Vocal-cord Radiotherapy
Focal radiotherapy limited to the involved vocal cord(s) plus additional margins accounting for respiration and set-up errors.
Active Comparator: Complete Larynx Radiotherapy Radiation: Complete Larynx Radiotherapy
Radiotherapy to the entire larynx, with target volumes defined to lead to traditional volumes from conventional complete larynx radiotherapy.


Outcome Measures
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Primary Outcome Measures :
  1. Local control [ Time Frame: At 2-year follow-up ]
    Local control rate of vocal-cord radiotherapy


Secondary Outcome Measures :
  1. Voice Handicap Index-10 score [ Time Frame: 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.

  2. MD Anderson Dysphagia Inventory score [ Time Frame: 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.

  3. MD Anderson Symptom Inventory-Head & Neck score [ Time Frame: 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.

  4. Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) [ Time Frame: 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.

  5. Rates of acute toxicity as per CTCAE v5.0 [ Time Frame: Week 0 post-treatment and at 2-month follow-up ]
  6. Rates of chronic toxicity as per CTCAE v5.0 [ Time Frame: At 6-month, 1-year, 2-year and 5-year post-treatment ]
  7. Rates of new hypothyroidism [ Time Frame: At 2- and 5-year follow-up ]
  8. Rates of cerebrovascular event (transient ischemic attack or stroke) [ Time Frame: At 5-year follow-up ]
  9. Overall survival [ Time Frame: At 2- and 5-year follow-up ]
  10. Time to recurrence [ Time Frame: At 2- and 5-year follow-up ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759431


Contacts
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Contact: Diane Trudel 514-890-8000 ext 11181 diane.dt.trudel.chum@ssss.gouv.qc.ca

Locations
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United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Victoria Cox    877-832-6789    vcox@mdanderson.org   
Principal Investigator: David I Rosenthal         
Sub-Investigator: Clifton D Fuller         
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Patricia Moore    519-685-8500    patricia.moore@lhc.on.ca   
Principal Investigator: David Palma         
Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montreal, Quebec, Canada, H2X 1R6
Contact: Diane Trudel    514-890-8000 ext 26906    diane.dt.trudel.chum@ssss.gouv.qc.ca   
Principal Investigator: Houda Bahig         
Sub-Investigator: Phuc-Félix Nguyen-Tan         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
London Health Sciences Centre
M.D. Anderson Cancer Center
Investigators
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Study Chair: Houda Bahig Centre hospitalier de l'Université de Montréal (CHUM)
Study Chair: David Palma London Health Sciences Centre
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03759431    
Other Study ID Numbers: 18.135
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: November 16, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
 Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases