<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/NCT03253939</url>
  </required_header>
  <id_info>
    <org_study_id>CYTO-CHIP</org_study_id>
    <nct_id>NCT03253939</nct_id>
  </id_info>
  <brief_title>Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Gastric Cancer</brief_title>
  <acronym>CYTO-CHIP</acronym>
  <official_title>Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Gastric cancer associated peritoneal carcinomatosis has a poor prognosis with a median&#xD;
      survival of less than one year. Systemic chemotherapy including targeted agents has not been&#xD;
      found to significantly increase the survival in Gastric cancer associated peritoneal&#xD;
      carcinomatosis. Since recurrent gastric cancer remains confined to the abdominal cavity in&#xD;
      many patients, regional therapies like aggressive cytoreductive surgery and hyperthermic&#xD;
      intraperitoneal chemotherapy have been investigated for Gastric cancer associated peritoneal&#xD;
      carcinomatosis. Hyperthermic intraperitoneal chemotherapy has been used for three indications&#xD;
      in Gastric Cancer- as an adjuvant therapy after a curative surgery, hyperthermic&#xD;
      intraperitoneal chemotherapy has been shown to improve survival and reduce peritoneal&#xD;
      recurrences in many randomised trials in Asian countries; as a definitive treatment in&#xD;
      established PC, hyperthermic intraperitoneal chemotherapy along with cytoreductive surgery is&#xD;
      the only therapeutic modality that has resulted in long-term survival in select groups of&#xD;
      patients. While the results of randomised trials of adjuvant hyperthermic intraperitoneal&#xD;
      chemotherapy from western centres are awaited, the role of hyperthermic intraperitoneal&#xD;
      chemotherapy in the treatment of Gastric cancer associated peritoneal carcinomatosis is still&#xD;
      evolving and needs larger studies before it is accepted as a standard of care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2017</completion_date>
  <primary_completion_date type="Actual">July 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>3-years overall survival</measure>
    <time_frame>3 years</time_frame>
    <description>From the date of Cytoreductive surgery + hyperthermic intraperitoneal chemotherapy to death or to the end of follow-up</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">275</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Peritoneal Carcinomatosis</condition>
  <arm_group>
    <arm_group_label>Case group</arm_group_label>
    <description>Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Cytoreductive surgery alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure</intervention_name>
    <description>Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure</description>
    <arm_group_label>Case group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cytoreductive surgery alone</intervention_name>
    <description>Exclusively Cytoreductive surgery approach</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with gastric peritoneal carcinomatosis. All patients received the current standard&#xD;
        neoadjuvant treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed peritoneal carcinomatosis from gastric cancer&#xD;
&#xD;
          -  Metachronous/synchronous peritoneal carcinomatosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Gastric origin of peritoneal carcinomatosis unconfirmed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Service de Chirurgie Générale et Digestive - Centre Hospitalier Lyon Sud - Hospices Civils de Lyon</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</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>Stomach Neoplasms</mesh_term>
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Peritoneal Neoplasms</mesh_term>
  </condition_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/NCT03253939
org study id: CYTO-CHIP
nct id: NCT03253939
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Gastric cancer associated peritoneal carcinomatosis has a poor prognosis with a median
      survival of less than one year. Systemic chemotherapy including targeted agents has not been
      found to significantly increase the survival in Gastric cancer associated peritoneal
      carcinomatosis. Since recurrent gastric cancer remains confined to the abdominal cavity in
      many patients, regional therapies like aggressive cytoreductive surgery and hyperthermic
      intraperitoneal chemotherapy have been investigated for Gastric cancer associated peritoneal
      carcinomatosis. Hyperthermic intraperitoneal chemotherapy has been used for three indications
      in Gastric Cancer- as an adjuvant therapy after a curative surgery, hyperthermic
      intraperitoneal chemotherapy has been shown to improve survival and reduce peritoneal
      recurrences in many randomised trials in Asian countries; as a definitive treatment in
      established PC, hyperthermic intraperitoneal chemotherapy along with cytoreductive surgery is
      the only therapeutic modality that has resulted in long-term survival in select groups of
      patients. While the results of randomised trials of adjuvant hyperthermic intraperitoneal
      chemotherapy from western centres are awaited, the role of hyperthermic intraperitoneal
      chemotherapy in the treatment of Gastric cancer associated peritoneal carcinomatosis is still
      evolving and needs larger studies before it is accepted as a standard of care.
observational model: Case-Control
time perspective: Retrospective
measure: 3-years overall survival
time frame: 3 years
description: From the date of Cytoreductive surgery + hyperthermic intraperitoneal chemotherapy to death or to the end of follow-up
arm group label: Case group
description: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
arm group label: Control group
description: Cytoreductive surgery alone
intervention type: Procedure
intervention name: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
description: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
arm group label: Case group
intervention type: Procedure
intervention name: Cytoreductive surgery alone
description: Exclusively Cytoreductive surgery approach
arm group label: Control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Carcinoma
mesh term: Peritoneal Neoplasms
sharing ipd: No