<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/NCT03772028</url>
  </required_header>
  <id_info>
    <org_study_id>M17OVH</org_study_id>
    <secondary_id>ENGOT-ov52/DGOG/OVHIPEC-2</secondary_id>
    <nct_id>NCT03772028</nct_id>
  </id_info>
  <brief_title>Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)</brief_title>
  <acronym>OVHIPEC-2</acronym>
  <official_title>Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Netherlands Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Netherlands Cancer Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or&#xD;
      without hyperthermic intraperitoneal chemotherapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to prove that treatment with primary cytoreductive surgery in&#xD;
      combination with HIPEC (treatment arm) improves outcome compared to primary cytoreductive&#xD;
      surgery without HIPEC (standard arm) with acceptable morbidity, in patients with FIGO stage&#xD;
      III epithelial ovarian cancer who are eligible for primary cytoreductive surgery with no&#xD;
      residual disease, or residual disease up to 2.5 mm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">April 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2025</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>randomized controlled, open-label, multicenter phase III trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>overall survival</measure>
    <time_frame>1 year after last patient last visit</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>recurrence-free survival</measure>
    <time_frame>1 year after last patient last visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>30 days after end of treatment</time_frame>
    <description>toxicity of extra treatment compared standaard treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cost evaluation</measure>
    <time_frame>1 year after lplv</time_frame>
    <description>cost evaluation based measured by quality adjusted life year</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">538</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>conventional surgery</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Primary cytoreductive surgery without HIPEC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIPEC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Primary cytoreductive surgery with HIPEC with cisplatin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cisplatin</intervention_name>
    <description>HIPEC with cisplatin after cytoreductive surgery</description>
    <arm_group_label>HIPEC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  candidate for primary CRS&#xD;
&#xD;
          -  histological or cytological proven FIGO stage III primary epithelial ovarian,&#xD;
             fallopian tube, or extra-ovarian cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of previous malignancies within 5 years prior to inclusion&#xD;
&#xD;
          -  FIGO stage IV disease&#xD;
&#xD;
          -  complete primary cytoreduction is impossible&#xD;
&#xD;
          -  prior treatment for the current malignancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>ovarian cancer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Willemien van Driel, MD, PhD</last_name>
    <phone>031 20 512 7918</phone>
    <email>OVHIPEC@nki.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lot Aronson</last_name>
    <phone>031 20 512 7918</phone>
    <email>OVHIPEC@nki.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>City of Hope</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thanh Dellinger, MD</last_name>
      <phone>626-256-4673</phone>
      <phone_ext>95200</phone_ext>
    </contact>
  </location>
  <location>
    <facility>
      <name>MSKCC New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bhavani Ramesh</last_name>
      <email>rameshb@mskcc.org</email>
    </contact>
    <investigator>
      <last_name>Oliver Zivanovic</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alice Bjoernlund-Larsen</last_name>
      <email>alice.bjoernlund-larsen@regionh.dk</email>
    </contact>
    <investigator>
      <last_name>Berit Jul Mosgaard</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Besancon</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nabila Bouazza</last_name>
      <email>Nabila.Bouazza@icm.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Laura Mansi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Bergonié</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nabila Bouazza</last_name>
      <email>Nabila.Bouazza@icm.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>F. Guyon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>o Institut Bergonié, Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nabila Bouazza</last_name>
      <email>Nabila.Bouazza@icm.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Frederic Guyon, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nabila Bouazza</last_name>
      <email>Nabila.Bouazza@icm.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Clarisse Eveno</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard, Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nabila B Bouazza</last_name>
      <email>Nabila.Bouazza@icm.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Pierre Meeus, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nabila B Bouazza</last_name>
      <email>Nabila.Bouazza@icm.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Naoual Bakrin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut du Cancer Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nabila Bouazza</last_name>
      <email>Nabila.Bouazza@icm.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Pierre-Emmanuel Colombo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut de Cancerologie de l'Ouest, ICO Nantes)</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nabila Bouazza</last_name>
      <email>Nabila.Bouazza@icm.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Charlotte Bourgin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Curie Paris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nabila Bouazza</last_name>
      <email>Nabila.Bouazza@icm.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Jean Guillaume FERON</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHRU Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nabila Bouazza</last_name>
      <email>Nabila.Bouazza@icm.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Cherif Akladios</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse)</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nabila Bouazza</last_name>
      <email>Nabila.Bouazza@icm.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Ferron Gwenael</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mater Misericordiae University Hospital, Dublin</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Terri Martin</last_name>
      <email>tmartin@mater.ie</email>
    </contact>
    <investigator>
      <last_name>Donal Brennan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Policlinico Sant'Orsola, Bologna</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Pierandrea De Iaco</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico A Gemelli IRCCS</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Deamicis</last_name>
      <email>andrea.deamicis@policlinicogemelli.it</email>
    </contact>
    <investigator>
      <last_name>Anna Fagotti</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Antoni van leeuwenhoek</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1066CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lot Aronson, PhD student</last_name>
      <email>l.aronson@nki.nl</email>
    </contact>
    <contact_backup>
      <last_name>Ruby van Stein, PhD student</last_name>
      <email>r.v.stein@nki.nl</email>
    </contact_backup>
    <investigator>
      <last_name>Willemien van Driel, dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Amsterdam UMC</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Catharina Hospital</name>
      <address>
        <city>Eindhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Medisch Spectrum Twente</name>
      <address>
        <city>Enschede</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UMCG</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Center (LUMC)</name>
      <address>
        <city>Leiden</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Maastricht UMC+</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Radboud MC</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UMCU</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>H.W.R. Schreuder, MD</last_name>
      <email>H.W.R.Schreuder@umcutrecht.nl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Alice Bjoernlund-Larsen</name>
      <address>
        <city>Uppsala</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alice Bjoernlund-Larsen</last_name>
      <email>alice.bjoernlund-larsen@regionh.dk</email>
    </contact>
    <investigator>
      <last_name>Marta Lomnytska</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>France</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Sweden</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ovarian cancer</keyword>
  <keyword>HIPEC</keyword>
  <keyword>OVHIPEC</keyword>
  <keyword>primary debulking</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
  </intervention_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/NCT03772028
org study id: M17OVH
secondary id: ENGOT-ov52/DGOG/OVHIPEC-2
nct id: NCT03772028
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or
      without hyperthermic intraperitoneal chemotherapy
The objective of this study is to prove that treatment with primary cytoreductive surgery in
      combination with HIPEC (treatment arm) improves outcome compared to primary cytoreductive
      surgery without HIPEC (standard arm) with acceptable morbidity, in patients with FIGO stage
      III epithelial ovarian cancer who are eligible for primary cytoreductive surgery with no
      residual disease, or residual disease up to 2.5 mm.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized controlled, open-label, multicenter phase III trial
primary purpose: Treatment
masking: None (Open Label)
measure: overall survival
time frame: 1 year after last patient last visit
measure: recurrence-free survival
time frame: 1 year after last patient last visit
measure: adverse events
time frame: 30 days after end of treatment
description: toxicity of extra treatment compared standaard treatment
measure: cost evaluation
time frame: 1 year after lplv
description: cost evaluation based measured by quality adjusted life year
arm group label: conventional surgery
arm group type: No Intervention
description: Primary cytoreductive surgery without HIPEC
arm group label: HIPEC
arm group type: Experimental
description: Primary cytoreductive surgery with HIPEC with cisplatin
intervention type: Drug
intervention name: cisplatin
description: HIPEC with cisplatin after cytoreductive surgery
arm group label: HIPEC
criteria: 
gender: Female
gender based: Yes
gender description: ovarian cancer
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Willemien van Driel, MD, PhD
phone: 031 20 512 7918
email: OVHIPEC@nki.nl
last name: Lot Aronson
phone: 031 20 512 7918
email: OVHIPEC@nki.nl
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
contact: 
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facility: 
status: Recruiting
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investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Denmark
country: France
country: Ireland
country: Italy
country: Netherlands
country: Sweden
country: United States
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Cisplatin