<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/NCT01709487</url>
  </required_header>
  <id_info>
    <org_study_id>HIPEC</org_study_id>
    <nct_id>NCT01709487</nct_id>
  </id_info>
  <brief_title>Feasibility Study of HIPEC for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy</brief_title>
  <official_title>Feasibility Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jules Bordet Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jules Bordet Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy&#xD;
      (HIPEC) after optimal debulking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Addition of HIPEC to the standard first line treatment of ovarian carcinoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 1/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>mortality rate</measure>
    <time_frame>24 weeks</time_frame>
    <description>We will record the mortality rate of our interventions: 3 cycles of pre-operative chemotherapy, surgery and HIPEC, 3 cycles of post-operative chemotherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression free survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Ovarian Carcinoma</condition>
  <condition>Fallopian Tube Carcinoma</condition>
  <condition>Primary Peritoneal Carcinoma</condition>
  <arm_group>
    <arm_group_label>HIPEC surgery with chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 courses of pre-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks&#xD;
Debulking surgery&#xD;
HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery&#xD;
3 courses of post-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>HIPEC</intervention_name>
    <description>HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery</description>
    <arm_group_label>HIPEC surgery with chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stage III or only pleural stage IV ovarian carcinoma first line treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  incomplete surgery poor performance status bad general condition&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph Kerger, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Jules Bordet, Brussels, Belgium.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Frédéric Goffin, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital de la Citadelle, Liège, Belgium.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de la Citadelle</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>February 23, 2016</last_update_submitted>
  <last_update_submitted_qc>February 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIPEC</keyword>
  <keyword>ovarian carcinoma</keyword>
  <keyword>Bordet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</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/NCT01709487
org study id: HIPEC
nct id: NCT01709487
lead sponsor: 
has dmc: No
First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy
      (HIPEC) after optimal debulking.
Addition of HIPEC to the standard first line treatment of ovarian carcinoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: mortality rate
time frame: 24 weeks
description: We will record the mortality rate of our interventions: 3 cycles of pre-operative chemotherapy, surgery and HIPEC, 3 cycles of post-operative chemotherapy.
measure: progression free survival
time frame: 3 years
measure: Overall survival
time frame: 3 years
arm group label: HIPEC surgery with chemotherapy
arm group type: Experimental
description: 3 courses of pre-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks
Debulking surgery
HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery
3 courses of post-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks
intervention type: Procedure
intervention name: HIPEC
description: HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery
arm group label: HIPEC surgery with chemotherapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joseph Kerger, M.D.
role: Principal Investigator
affiliation: Institut Jules Bordet, Brussels, Belgium.
last name: Frédéric Goffin, M.D.
role: Principal Investigator
affiliation: Hopital de la Citadelle, Liège, Belgium.
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial