xml: <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/NCT05996276</url>
    </required_header>
    <id_info>
      <org_study_id>29BRC23.0144 - SATIATION</org_study_id>
      <nct_id>NCT05996276</nct_id>
    </id_info>
    <brief_title>Impact of Dose to Cardiac Substructures on Survival in Patients With Esophageal Cancer Treated With Radiotherapy or Chemoradiotherapy (SATIATION)</brief_title>
    <acronym>SATIATION</acronym>
    <official_title>Impact of Dose to Cardiac Substructures on Survival in Patients With Esophageal Cancer Treated With Radiotherapy or Chemoradiotherapy</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>
        Treatment of non-operable esophageal cancers is based on radiochemotherapy, or exclusive&#xD;
        radiotherapy.&#xD;
  &#xD;
        The cardiac toxicity of radiotherapy in the treatment of thoracic tumor localizations is well&#xD;
        documented, however, more and more studies are calling for the use of dosimetric parameters&#xD;
        related to cardiac sub-structures to be integrated into clinical practice, rather than&#xD;
        considering the heart as a whole.&#xD;
  &#xD;
        With this in mind, the aim of this study is to define the parameters, particularly dosimetric&#xD;
        ones linked to cardiac sub-structures, influencing survival in patients treated with&#xD;
        exclusive radiotherapy or radiochemotherapy for esophageal cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Treatment of non-operable esophageal cancers is based on radiochemotherapy, or exclusive&#xD;
        radiotherapy.&#xD;
  &#xD;
        The cardiac toxicity of radiotherapy in the treatment of thoracic tumor localizations is well&#xD;
        documented, however, more and more studies are calling for the use of dosimetric parameters&#xD;
        related to cardiac sub-structures to be integrated into clinical practice, rather than&#xD;
        considering the heart as a whole.&#xD;
  &#xD;
        Although most of these data have been studied in populations with long-term follow-up, such&#xD;
        as breast cancer, cardiac toxicity and the reduced survival it entails are also found in&#xD;
        diseases such as esophageal cancer.&#xD;
  &#xD;
        With this in mind, the aim of this study is to define the parameters, particularly dosimetric&#xD;
        ones linked to cardiac sub-structures, influencing survival in patients treated with&#xD;
        exclusive radiotherapy or radiochemotherapy for esophageal cancer.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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>Overall survival (OS)</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>OS is defined as the time elapsed between inclusion and death, whatever the cause.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The rate of cardiac events.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The rate of cardiac events.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Response rate.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Response rate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS).</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>PFS is defined as the time elapsed between inclusion and tumor progression assessed by an expert panel according to RECIST v1.1 criteria, or death from any cause.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Esophagus Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Non-operated adult patients with localized or locally advanced esophageal cancer treated&#xD;
          with radiochemotherapy or radiotherapy alone for curative purposes.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Histologically or cytologically proven esophageal cancer&#xD;
  &#xD;
            -  Localized or locally advanced esophageal cancer treated with radiochemotherapy or&#xD;
               exclusive radiotherapy&#xD;
  &#xD;
            -  Tumor dose ≥ 50 Gy&#xD;
  &#xD;
            -  Non-opposition of living patients formulated&#xD;
  &#xD;
            -  Patient affiliated to a social security scheme&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt; 18 years&#xD;
  &#xD;
            -  Patient treated with upfront surgery&#xD;
  &#xD;
            -  Tumor dose &lt; 50 Gy&#xD;
  &#xD;
            -  Other concomitant neoplasia&#xD;
  &#xD;
            -  Metastatic patient&#xD;
  &#xD;
            -  Refusal to participate&#xD;
  &#xD;
            -  Patient under legal protection (guardianship, curatorship, etc...)&#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>Vincent Bourbonne, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Radiation Oncology Department, Brest University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Vincent BOURBONNE, MD, PhD</last_name>
      <phone>+33298223398</phone>
      <email>vincent.bourbonne@chu-brest.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chu Brest</name>
        <address>
          <city>Brest</city>
          <zip>29609</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Vincent Bourbonne, MD, PhD</last_name>
        <phone>+33298223398</phone>
        <email>vincent.bourbonne@chu-brest.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>radiotherapy; cardiotoxicity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Esophageal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All collected data that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Data will be available beginning three years and ending fifteen years following the final study report completion</ipd_time_frame>
      <ipd_access_criteria>Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996276
  org study id: 29BRC23.0144 - SATIATION
  nct id: NCT05996276
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Treatment of non-operable esophageal cancers is based on radiochemotherapy, or exclusive
        radiotherapy.
  
        The cardiac toxicity of radiotherapy in the treatment of thoracic tumor localizations is well
        documented, however, more and more studies are calling for the use of dosimetric parameters
        related to cardiac sub-structures to be integrated into clinical practice, rather than
        considering the heart as a whole.
  
        With this in mind, the aim of this study is to define the parameters, particularly dosimetric
        ones linked to cardiac sub-structures, influencing survival in patients treated with
        exclusive radiotherapy or radiochemotherapy for esophageal cancer.
  Treatment of non-operable esophageal cancers is based on radiochemotherapy, or exclusive
        radiotherapy.
  
        The cardiac toxicity of radiotherapy in the treatment of thoracic tumor localizations is well
        documented, however, more and more studies are calling for the use of dosimetric parameters
        related to cardiac sub-structures to be integrated into clinical practice, rather than
        considering the heart as a whole.
  
        Although most of these data have been studied in populations with long-term follow-up, such
        as breast cancer, cardiac toxicity and the reduced survival it entails are also found in
        diseases such as esophageal cancer.
  
        With this in mind, the aim of this study is to define the parameters, particularly dosimetric
        ones linked to cardiac sub-structures, influencing survival in patients treated with
        exclusive radiotherapy or radiochemotherapy for esophageal cancer.
  observational model: Cohort
  time perspective: Retrospective
  measure: Overall survival (OS)
  time frame: through study completion, an average of 1 year
  description: OS is defined as the time elapsed between inclusion and death, whatever the cause.
  measure: The rate of cardiac events.
  time frame: through study completion, an average of 1 year
  description: The rate of cardiac events.
  measure: Response rate.
  time frame: through study completion, an average of 1 year
  description: Response rate.
  measure: Progression-free survival (PFS).
  time frame: through study completion, an average of 1 year
  description: PFS is defined as the time elapsed between inclusion and tumor progression assessed by an expert panel according to RECIST v1.1 criteria, or death from any cause.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Vincent Bourbonne, MD, PhD
  role: Principal Investigator
  affiliation: Radiation Oncology Department, Brest University Hospital
  last name: Vincent BOURBONNE, MD, PhD
  phone: +33298223398
  email: vincent.bourbonne@chu-brest.fr
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Esophageal Neoplasms
  sharing ipd: Yes
  ipd description: All collected data that underlie results in a publication
  ipd info type: Study Protocol
  ipd time frame: Data will be available beginning three years and ending fifteen years following the final study report completion
  ipd access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement