<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/NCT03822897</url>
  </required_header>
  <id_info>
    <org_study_id>HN10</org_study_id>
    <nct_id>NCT03822897</nct_id>
  </id_info>
  <brief_title>De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma</brief_title>
  <acronym>EVADER</acronym>
  <official_title>A Phase II Single Arm Trial of Elective Volume Adjusted De-Escalation Radiotherapy (EVADER) in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Canadian Cancer Trials Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Canadian Cancer Trials Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out whether radiotherapy to some of the lymph node areas&#xD;
      can be safely omitted to decrease side effects without increasing the risk of the tumour&#xD;
      coming back.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The standard or usual treatment for this disease includes radiotherapy or radiotherapy&#xD;
      combined with chemotherapy or antibody therapy.&#xD;
&#xD;
      These treatments are highly effective at curing most patients with HPV-related cancer of the&#xD;
      oropharynx, but short and long-term side effects from treatment can be significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 28, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Event-free Survival</measure>
    <time_frame>5 years</time_frame>
    <description>Time to first progress event or censoring in year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>5 years</time_frame>
    <description>Time to death or censoring in year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local control</measure>
    <time_frame>5 years</time_frame>
    <description>Percentage of patients with local control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional Control</measure>
    <time_frame>5 years</time_frame>
    <description>Percentage of patients with regional control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional control</measure>
    <time_frame>5 years</time_frame>
    <description>Percentage of patients with local and regional control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant Metastasis-Free Survival</measure>
    <time_frame>5 years</time_frame>
    <description>Time to distant metastasis or censoring in year</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>Oropharyngeal Cancer</condition>
  <arm_group>
    <arm_group_label>Two Treatment Options</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks&#xD;
Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation</intervention_name>
    <description>35 fractions, 5/wk, 7 wks 70Gy/56Gy, or&#xD;
35 fractions, 6/wk, 6 wks, 70Gy/56Gy, or&#xD;
35 fractions, 5/wk, 7 wks OR 6/wk, 6 wks 70Gy/56Gy</description>
    <arm_group_label>Two Treatment Options</arm_group_label>
    <other_name>No available</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>100 mg/m2 on day 1, 22, and 43 or 40 mg/m2 /wk for 7 wks</description>
    <arm_group_label>Two Treatment Options</arm_group_label>
    <other_name>No available</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with pathologically proven diagnosis of HPV-related OPSCC&#xD;
&#xD;
          -  Clinical stage T1-3 N0-1 M0 (UICC/AJCC 8th Ed.)&#xD;
&#xD;
          -  Patients must be eligible for definitive RT or CRT&#xD;
&#xD;
          -  Must be ≥ 18 years of age&#xD;
&#xD;
          -  Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or&#xD;
             2&#xD;
&#xD;
          -  Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life&#xD;
             and health economics questionnaires in either English or French&#xD;
&#xD;
          -  Patient consent must be appropriately obtained in accordance with applicable local and&#xD;
             regulatory requirements. Each patient must sign a consent form prior to enrolment in&#xD;
             the trial to document their willingness to participate&#xD;
&#xD;
          -  Patients must be accessible for treatment and follow-up. Investigators must assure&#xD;
             themselves the patients enrolled on this trial will be available for complete&#xD;
             documentation of the treatment, adverse events, and follow-up.&#xD;
&#xD;
          -  In accordance with CCTG policy, protocol treatment is to begin within 3 weeks of&#xD;
             patient registration&#xD;
&#xD;
          -  Women/men of childbearing potential must have agreed to use a highly effective&#xD;
             contraceptive method&#xD;
&#xD;
          -  The following radiological investigations must be done within 8 weeks of&#xD;
             randomization: CT or MR of head and neck (MRI is recommended for base-of-tongue&#xD;
             primary tumors); PET-CT scan.&#xD;
&#xD;
          -  Patient must consent to provision of, and investigator(s) must confirm location and&#xD;
             commit to obtain a representation of formalin-fixed paraffin block of non-cytology&#xD;
             tumour tissue in order that the specific correlative marker assays described in&#xD;
             Section 12 (Correlative Studies) may be conducted. Please see the Correlative Manual&#xD;
             for details&#xD;
&#xD;
          -  Patient must consent to provision of samples of blood and plasma (for circulating cell&#xD;
             free DNA) in order that the specific correlative marker assays described may be&#xD;
             conducted.&#xD;
&#xD;
          -  Patients with prior or concurrent malignancy whose natural history or treatment does&#xD;
             not have the potential to interfere with the safety or efficacy assessment of the&#xD;
             investigational regimen are eligible for this trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous chemotherapy or radiotherapy treatment for head and neck cancer&#xD;
&#xD;
          -  Patients with an unknown primary.&#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>Scott Bratman</last_name>
    <role>Study Chair</role>
    <affiliation>Princess Margaret Cancer Centre, Toronto, ON</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BCCA - Centre for the North</name>
      <address>
        <city>Prince George</city>
        <state>British Columbia</state>
        <zip>V2M 7E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BCCA - Vancouver Cancer Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CancerCare Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 0V9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. H. Bliss Murphy Cancer Centre</name>
      <address>
        <city>St. John's</city>
        <state>Newfoundland and Labrador</state>
        <zip>A1B 3V6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Centre at Hamilton Health Sciences</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingston Health Sciences Centre</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odette Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Research Institute of the McGill University</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hotel-Dieu de Quebec</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1R 2J6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIUSSS de l'Estrie - Centre hospitalier</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allan Blair Cancer Centre</name>
      <address>
        <city>Regina</city>
        <state>Saskatchewan</state>
        <zip>S4T 7T1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</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>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Oropharyngeal Neoplasms</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03822897
org study id: HN10
nct id: NCT03822897
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to find out whether radiotherapy to some of the lymph node areas
      can be safely omitted to decrease side effects without increasing the risk of the tumour
      coming back.
The standard or usual treatment for this disease includes radiotherapy or radiotherapy
      combined with chemotherapy or antibody therapy.

      These treatments are highly effective at curing most patients with HPV-related cancer of the
      oropharynx, but short and long-term side effects from treatment can be significant.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Event-free Survival
time frame: 5 years
description: Time to first progress event or censoring in year
measure: Overall Survival
time frame: 5 years
description: Time to death or censoring in year
measure: Local control
time frame: 5 years
description: Percentage of patients with local control
measure: Regional Control
time frame: 5 years
description: Percentage of patients with regional control
measure: Locoregional control
time frame: 5 years
description: Percentage of patients with local and regional control
measure: Distant Metastasis-Free Survival
time frame: 5 years
description: Time to distant metastasis or censoring in year
arm group label: Two Treatment Options
arm group type: Other
description: Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks
Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy
intervention type: Radiation
intervention name: Radiation
description: 35 fractions, 5/wk, 7 wks 70Gy/56Gy, or
35 fractions, 6/wk, 6 wks, 70Gy/56Gy, or
35 fractions, 5/wk, 7 wks OR 6/wk, 6 wks 70Gy/56Gy
arm group label: Two Treatment Options
other name: No available
intervention type: Drug
intervention name: Cisplatin
description: 100 mg/m2 on day 1, 22, and 43 or 40 mg/m2 /wk for 7 wks
arm group label: Two Treatment Options
other name: No available
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Scott Bratman
role: Study Chair
affiliation: Princess Margaret Cancer Centre, Toronto, ON
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Carcinoma, Squamous Cell
mesh term: Oropharyngeal Neoplasms
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Cisplatin
sharing ipd: No