<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/NCT03265873</url>
  </required_header>
  <id_info>
    <org_study_id>DBU_2017_13</org_study_id>
    <nct_id>NCT03265873</nct_id>
  </id_info>
  <brief_title>Contribution of the ENT (Ear, Nose, and Throat) Surgeon's Clinical Evaluation to the Contouring of Target Volumes and Organs Eligible for Radiotherapy in Head and Neck Cancers</brief_title>
  <acronym>CONTOUR</acronym>
  <official_title>Contribution of the ENT Surgeon's Clinical Evaluation to the Contouring of Target Volumes and Organs Eligible for Radiotherapy in Head and Neck Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</source>
  <oversight_info>
    <has_dmc>No</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>
      Radiotherapy (RT), surgery and chemotherapy (CT) are treatments for head and neck cancers,&#xD;
      used alone or in combination. Conformal RT with Intensity Modulation (IMRT) is currently the&#xD;
      reference technique. IMRT requires a precise definition of the target volumes to be treated&#xD;
      and the anatomical structures to be protected from irradiation. Most studies of head and neck&#xD;
      cancers published in the literature demonstrate the variability in the contouring of the&#xD;
      target volumes between radiotherapists. This may have an impact on dosimetry. To date, no&#xD;
      studies have evaluated the impact of the ENT surgeon's evaluation in volumes contouring. The&#xD;
      aim of this study is to compare the volumes determined by the radiotherapists alone and those&#xD;
      determined jointly by the radiotherapists and the ENT surgeon.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 28, 2017</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with head and neck cancer for whom a change in the CTV (Clinical Target Volume) was made following the advice of the ENT surgeon.</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Radiotherapy, Conformal (IMRT)</condition>
  <condition>Head and Neck Cancer</condition>
  <condition>Otolaryngology</condition>
  <condition>Surgeons</condition>
  <condition>Radiation Oncologists</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Systematic consideration of the advice of the ENT surgeon in the determination of the radiotherapy target volumes in head and neck cancers.</intervention_name>
    <description>The contouring of the different target volumes will be first performed by the radiotherapists. During the Head and Neck Tumor Board, the volumes initially determined by the radiotherapists will be analyzed jointly by the radiotherapists and the patient's ENT surgeon to carry out, if necessary, modifications, taking into account clinical observations, intraoperative findings (if any) and endoscopy findings. Concordance parameters will be calculated in a second time with the determined volumes (in particular, index of concordance, coefficient of similarity).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with head and neck cancer who require radiotherapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years;&#xD;
&#xD;
          -  Cancer of the upper aerodigestive tract (oral cavity, oropharynx, larynx, hypopharynx,&#xD;
             rhinopharynx, salivary glands, facial sinuses, orbital cavity, ear);&#xD;
&#xD;
          -  Cancer confirmed by histopathological analysis;&#xD;
&#xD;
          -  Therapeutic protocol including radiotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any history of radiotherapy of the head and neck&#xD;
&#xD;
          -  Synchronous head and neck cancer.&#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>Philippe Clément, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital d'Instruction des armées Percy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laurence Salomon, MD PhD</last_name>
    <phone>0148036431</phone>
    <phone_ext>+33</phone_ext>
    <email>lsalomon@for.paris</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daniel Brasnu, MD</last_name>
    <phone>0148036839</phone>
    <phone_ext>+33</phone_ext>
    <email>dbrasnu@for.paris</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital d'Instruction des Armées</name>
      <address>
        <city>Clamart</city>
        <zip>92140</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Philippe Clément, MD</last_name>
      <phone>0141466172</phone>
      <phone_ext>+33</phone_ext>
      <email>phclement@wanadoo.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondation Ophtalmologique A. de Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Brasnu, MD</last_name>
      <phone>0148036839</phone>
      <phone_ext>+33</phone_ext>
      <email>dbrasnu@for.paris</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>February 11, 2023</last_update_submitted>
  <last_update_submitted_qc>February 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 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>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03265873
org study id: DBU_2017_13
nct id: NCT03265873
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Radiotherapy (RT), surgery and chemotherapy (CT) are treatments for head and neck cancers,
      used alone or in combination. Conformal RT with Intensity Modulation (IMRT) is currently the
      reference technique. IMRT requires a precise definition of the target volumes to be treated
      and the anatomical structures to be protected from irradiation. Most studies of head and neck
      cancers published in the literature demonstrate the variability in the contouring of the
      target volumes between radiotherapists. This may have an impact on dosimetry. To date, no
      studies have evaluated the impact of the ENT surgeon's evaluation in volumes contouring. The
      aim of this study is to compare the volumes determined by the radiotherapists alone and those
      determined jointly by the radiotherapists and the ENT surgeon.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Proportion of patients with head and neck cancer for whom a change in the CTV (Clinical Target Volume) was made following the advice of the ENT surgeon.
time frame: Baseline
intervention type: Other
intervention name: Systematic consideration of the advice of the ENT surgeon in the determination of the radiotherapy target volumes in head and neck cancers.
description: The contouring of the different target volumes will be first performed by the radiotherapists. During the Head and Neck Tumor Board, the volumes initially determined by the radiotherapists will be analyzed jointly by the radiotherapists and the patient's ENT surgeon to carry out, if necessary, modifications, taking into account clinical observations, intraoperative findings (if any) and endoscopy findings. Concordance parameters will be calculated in a second time with the determined volumes (in particular, index of concordance, coefficient of similarity).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe Clément, MD
role: Principal Investigator
affiliation: Hôpital d'Instruction des armées Percy
last name: Laurence Salomon, MD PhD
phone: 0148036431
phone ext: +33
email: lsalomon@for.paris
last name: Daniel Brasnu, MD
phone: 0148036839
phone ext: +33
email: dbrasnu@for.paris
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
sharing ipd: Undecided