<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/NCT03841175</url>
  </required_header>
  <id_info>
    <org_study_id>RENOVATE ( 29BRC18.0012)</org_study_id>
    <nct_id>NCT03841175</nct_id>
  </id_info>
  <brief_title>Forecasts Impact of the Pre-therapeutic TEP-TDM in the 18-FDG Restaging of Upper Aero-digestive Tract Cancers</brief_title>
  <acronym>RENOVATE</acronym>
  <official_title>Forecasts Impact of the Pre-therapeutic TEP-TDM in the 18-FDG Restaging of Upper Aero-digestive Tract Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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>
      Head and neck (HN) cancer is the sixth most common malignancy worldwide, with around 800 000&#xD;
      new cases and 320 000 deaths in 2015. These malignancies encompass cancers of the oral&#xD;
      cavity, oropharynx, hypopharynx and larynx and concern squamous cell carcinomas (HNSCC) 90%&#xD;
      of the time. Despite aggressive treatment strategies, the five-year survival rate has only&#xD;
      marginally improved in the past decade. The prognosis is strongly dependent on initial&#xD;
      staging. The 5-year relative survival rate is 80,3% for patients with localized disease&#xD;
      whereas it decreases to 47.2% when regional lymph node metastasis is known, and to 32.5% when&#xD;
      distant metastasis is known. Hence, precise cancer staging is essential as it allows&#xD;
      clinicians to select the appropriate treatment strategies and predict the prognosis of the&#xD;
      patients.&#xD;
&#xD;
      The conventional work-up (CWU) includes physical examination, endoscopy, computed tomography&#xD;
      (CT) and/or magnetic resonance imaging (MRI) of the head and neck to evaluate the initial&#xD;
      local and regional HNSCC staging. Thoracic CT is recommended because the thorax is the most&#xD;
      frequent location of remote metastasis and synchronous second cancer outside of the upper&#xD;
      aerodigestive tract.&#xD;
&#xD;
      Some authors demonstrated that 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography&#xD;
      (PET) had a higher sensitivity and specificity for determining the extent of the disease and&#xD;
      was able to detect occult second primaries. Moreover 18-FDG PET-CT allows whole body&#xD;
      assessment. This is why the use of 18-FDG PET-CT has increased significantly over the last&#xD;
      several years. Added to initial CWU, 18-FDG PET-CT may restage HNSCC and as a result may&#xD;
      alter the clinical management.&#xD;
&#xD;
      Pre-therapeutic 18F-FDG PET/CT is recommended by guidelines to assess remote extension of&#xD;
      locally advanced HNSCC and/or to look for synchronous cancer but is not systematically&#xD;
      indicated, particularly for localized disease.&#xD;
&#xD;
      Restaging impact on prognosis and clinical management remains poorly understood.&#xD;
&#xD;
      Therefore, the objective of this study is to assess the impact of the additional information&#xD;
      provided by 18F-FDG PET-CT on HNSCC initial staging and whether restaging modify prognosis&#xD;
      and clinical management, whatever the CWU stage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prognostic impact of initial restaging HNSCC with 18F-FDG PET-CT</measure>
    <time_frame>10 years</time_frame>
    <description>Overall survival</description>
  </primary_outcome>
  <enrollment type="Actual">477</enrollment>
  <condition>Cancer of Head and Neck</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients referred for a pre-treatment FDG PET/CT of biopsy proven HSNCC&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  biopsy proven HSNCC&#xD;
&#xD;
          -  written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous head and neck malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>February 13, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Squamous cell carcinoma</keyword>
  <keyword>FDG PET/CT</keyword>
  <keyword>Initial staging</keyword>
  <keyword>Clinical management</keyword>
  <keyword>Prognosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck 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/NCT03841175
org study id: RENOVATE ( 29BRC18.0012)
nct id: NCT03841175
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Head and neck (HN) cancer is the sixth most common malignancy worldwide, with around 800 000
      new cases and 320 000 deaths in 2015. These malignancies encompass cancers of the oral
      cavity, oropharynx, hypopharynx and larynx and concern squamous cell carcinomas (HNSCC) 90%
      of the time. Despite aggressive treatment strategies, the five-year survival rate has only
      marginally improved in the past decade. The prognosis is strongly dependent on initial
      staging. The 5-year relative survival rate is 80,3% for patients with localized disease
      whereas it decreases to 47.2% when regional lymph node metastasis is known, and to 32.5% when
      distant metastasis is known. Hence, precise cancer staging is essential as it allows
      clinicians to select the appropriate treatment strategies and predict the prognosis of the
      patients.

      The conventional work-up (CWU) includes physical examination, endoscopy, computed tomography
      (CT) and/or magnetic resonance imaging (MRI) of the head and neck to evaluate the initial
      local and regional HNSCC staging. Thoracic CT is recommended because the thorax is the most
      frequent location of remote metastasis and synchronous second cancer outside of the upper
      aerodigestive tract.

      Some authors demonstrated that 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography
      (PET) had a higher sensitivity and specificity for determining the extent of the disease and
      was able to detect occult second primaries. Moreover 18-FDG PET-CT allows whole body
      assessment. This is why the use of 18-FDG PET-CT has increased significantly over the last
      several years. Added to initial CWU, 18-FDG PET-CT may restage HNSCC and as a result may
      alter the clinical management.

      Pre-therapeutic 18F-FDG PET/CT is recommended by guidelines to assess remote extension of
      locally advanced HNSCC and/or to look for synchronous cancer but is not systematically
      indicated, particularly for localized disease.

      Restaging impact on prognosis and clinical management remains poorly understood.

      Therefore, the objective of this study is to assess the impact of the additional information
      provided by 18F-FDG PET-CT on HNSCC initial staging and whether restaging modify prognosis
      and clinical management, whatever the CWU stage.
observational model: Cohort
time perspective: Retrospective
measure: Prognostic impact of initial restaging HNSCC with 18F-FDG PET-CT
time frame: 10 years
description: Overall survival
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms