<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03759431</url>
  </required_header>
  <id_info>
    <org_study_id>18.135</org_study_id>
    <nct_id>NCT03759431</nct_id>
  </id_info>
  <brief_title>Vocal-cord vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer</brief_title>
  <acronym>VOCAL</acronym>
  <official_title>A Randomized Study of Vocal-cord Only vs. Complete Laryngeal Radiotherapy for Early Glottic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>London Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicentrer, randomized Bayesian Phase II trial for patients with early stage&#xD;
      (T1N0) glottic squamous cell carcinoma treated with radical radiotherapy. The primary&#xD;
      objective is to assess the non-inferiority of local control achieved with vocal-cord only&#xD;
      radiotherapy (VC-RT) compared to complete larynx radiotherapy (CL-RT) in T1N0 glottic&#xD;
      laryngeal squamous cell cancer, measured at 2-years after treatment. Secondary outcomes&#xD;
      include overall survival, as well as voice impairment, dysphagia and quality of life,&#xD;
      measured respectively by the voice handicap index -10 (VHI-10), the MD Anderson Dysphagia&#xD;
      Inventory (MDADI) and the MD Anderson Symptom Inventory- Head and Neck module (MDASI-HN).&#xD;
      Patients will be randomized in a 1:3 ratio to CL-RT (39 patients) and VC-RT (116 patients)&#xD;
      arms. There will be stratification by tumor stage (T1a/T1b) and by institution. An interim&#xD;
      analysis is planned after the first 55 patients enrolled on the experimental arm have a&#xD;
      6-month follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 11, 2018</start_date>
  <completion_date type="Anticipated">December 12, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 12, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Local control</measure>
    <time_frame>At 2-year follow-up</time_frame>
    <description>Local control rate of vocal-cord radiotherapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Voice Handicap Index-10 score</measure>
    <time_frame>Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MD Anderson Dysphagia Inventory score</measure>
    <time_frame>Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up</time_frame>
    <description>Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MD Anderson Symptom Inventory-Head &amp; Neck score</measure>
    <time_frame>Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)</measure>
    <time_frame>Week 0 post-treatment and at 6-month follow-up</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of acute toxicity as per CTCAE v5.0</measure>
    <time_frame>Week 0 post-treatment and at 2-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of chronic toxicity as per CTCAE v5.0</measure>
    <time_frame>At 6-month, 1-year, 2-year and 5-year post-treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of new hypothyroidism</measure>
    <time_frame>At 2- and 5-year follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of cerebrovascular event (transient ischemic attack or stroke)</measure>
    <time_frame>At 5-year follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>At 2- and 5-year follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to recurrence</measure>
    <time_frame>At 2- and 5-year follow-up</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">155</enrollment>
  <condition>Cancer Neck</condition>
  <condition>Larynx Cancer</condition>
  <condition>Glottis Tumor</condition>
  <arm_group>
    <arm_group_label>Vocal-cord Radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Complete Larynx Radiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Vocal-cord Radiotherapy</intervention_name>
    <description>Focal radiotherapy limited to the involved vocal cord(s) plus additional margins accounting for respiration and set-up errors.</description>
    <arm_group_label>Vocal-cord Radiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Complete Larynx Radiotherapy</intervention_name>
    <description>Radiotherapy to the entire larynx, with target volumes defined to lead to traditional volumes from conventional complete larynx radiotherapy.</description>
    <arm_group_label>Complete Larynx Radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage T1a-b N0 of the true vocal cords planned for definitive RT&#xD;
&#xD;
          -  Patient not candidate for laser surgery or declined laser surgery&#xD;
&#xD;
          -  Biopsy-confirmed squamous cell carcinoma, including verrucous carcinoma&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status 0-2&#xD;
&#xD;
          -  Ability to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous irradiation of the head and neck (HNC) region&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Any medical condition that represents, in the opinion of the investigator, a&#xD;
             contraindication to radiotherapy or would prevent follow-up after radiotherapy.&#xD;
&#xD;
          -  Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free&#xD;
             for a minimum of 2 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Houda Bahig</last_name>
    <role>Study Chair</role>
    <affiliation>Centre hospitalier de l'Université de Montréal (CHUM)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Palma</last_name>
    <role>Study Chair</role>
    <affiliation>London Health Sciences Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Diane Trudel</last_name>
    <phone>514-890-8000</phone>
    <phone_ext>11181</phone_ext>
    <email>diane.dt.trudel.chum@ssss.gouv.qc.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>The University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Victoria Cox</last_name>
      <phone>877-832-6789</phone>
      <email>vcox@mdanderson.org</email>
    </contact>
    <investigator>
      <last_name>David I Rosenthal</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Clifton D Fuller</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patricia Moore</last_name>
      <phone>519-685-8500</phone>
      <email>patricia.moore@lhc.on.ca</email>
    </contact>
    <investigator>
      <last_name>David Palma</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montréal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 1R6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diane Trudel</last_name>
      <phone>514-890-8000</phone>
      <phone_ext>26906</phone_ext>
      <email>diane.dt.trudel.chum@ssss.gouv.qc.ca</email>
    </contact>
    <investigator>
      <last_name>Houda Bahig</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Phuc-Félix Nguyen-Tan</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 10, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 11, 2022</last_update_submitted>
  <last_update_submitted_qc>November 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Laryngeal Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03759431
org study id: 18.135
nct id: NCT03759431
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Local control
time frame: At 2-year follow-up
description: Local control rate of vocal-cord radiotherapy
measure: Voice Handicap Index-10 score
time frame: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up
description: 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.
measure: MD Anderson Dysphagia Inventory score
time frame: Week 0 post-treatment, and at 2-month, 6-month, 1-year and 2-year follow-up
description: Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life.
measure: 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
description: 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.
measure: Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
time frame: Week 0 post-treatment and at 6-month follow-up
description: 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.
measure: Rates of acute toxicity as per CTCAE v5.0
time frame: Week 0 post-treatment and at 2-month follow-up
measure: Rates of chronic toxicity as per CTCAE v5.0
time frame: At 6-month, 1-year, 2-year and 5-year post-treatment
measure: Rates of new hypothyroidism
time frame: At 2- and 5-year follow-up
measure: Rates of cerebrovascular event (transient ischemic attack or stroke)
time frame: At 5-year follow-up
measure: Overall survival
time frame: At 2- and 5-year follow-up
measure: Time to recurrence
time frame: At 2- and 5-year follow-up
arm group label: Vocal-cord Radiotherapy
arm group type: Experimental
arm group label: Complete Larynx Radiotherapy
arm group type: Active Comparator
intervention type: Radiation
intervention name: Vocal-cord Radiotherapy
description: Focal radiotherapy limited to the involved vocal cord(s) plus additional margins accounting for respiration and set-up errors.
arm group label: Vocal-cord Radiotherapy
intervention type: Radiation
intervention name: Complete Larynx Radiotherapy
description: Radiotherapy to the entire larynx, with target volumes defined to lead to traditional volumes from conventional complete larynx radiotherapy.
arm group label: Complete Larynx Radiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Houda Bahig
role: Study Chair
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
last name: David Palma
role: Study Chair
affiliation: London Health Sciences Centre
last name: Diane Trudel
phone: 514-890-8000
phone ext: 11181
email: diane.dt.trudel.chum@ssss.gouv.qc.ca
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Laryngeal Neoplasms