<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/NCT03025477</url>
  </required_header>
  <id_info>
    <org_study_id>RVT_2015_2</org_study_id>
    <nct_id>NCT03025477</nct_id>
  </id_info>
  <brief_title>Two Therapeutic Strategies in First-line in Patients With Epithelial Advanced Ovarian Cancer</brief_title>
  <acronym>CHIMOVIP</acronym>
  <official_title>Randomized Study Assessing Two Strategies of First Line: a Strategy With Intraperitoneal Chemotherapy and a Strategy With Total Intravenous Strategy, in Patients With Epithelial Advanced Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Hospitalier Diaconesses Croix Saint-Simon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GERCOR - Multidisciplinary Oncology Cooperative Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Groupe Hospitalier Diaconesses Croix Saint-Simon</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian&#xD;
      advanced cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized phase II study, open-label and multicentric. After initial intervention&#xD;
      (debulking surgery or diagnostic surgery) patient will randomized in the study according to&#xD;
      Completeness of cytoreduction (CC) score (CC0 or CC&gt;1).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Anticipated">October 2032</completion_date>
  <primary_completion_date type="Anticipated">October 2021</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pathological complete peritoneal response (pCR)</measure>
    <time_frame>2-year</time_frame>
    <description>Interval debulking surgery or final evaluation peritoneal surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QLQ -C30) assessment</measure>
    <time_frame>Up to 2-year (at inclusion, after 3 cycles and end of treatment)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QLQ-OV28) assessment</measure>
    <time_frame>Up to 2-year (at inclusion, after 3 cycles and end of treatment)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IPSS score</measure>
    <time_frame>Up to 2-year (at inclusion, after 3 cycles and end of treatment)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with treatment-related adverse events as assessed by CTCAE version 4.03</measure>
    <time_frame>2-year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free survival (EFS)</measure>
    <time_frame>At 5-year and 10-year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate at the various surgical step</measure>
    <time_frame>Up to 2-year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>At 5-year and 10-year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Ovarian Cancer, Epithelial</condition>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Initial or interval surgery associated with 6 cycles of chemotherapy in intravenous (IV) of carboplatin and paclitaxel.&#xD;
The regimen of administration of the chemotherapy is as following:&#xD;
Carboplatin AUC 6 - IV - Day (D) 1&#xD;
Paclitaxel 80mg / m² - IV - D1, D8, D15&#xD;
one cycle every 3 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initial or interval surgery associated with 6 cycles of chemotherapy of cisplatin and epirubicin.&#xD;
Cisplatin is administrated in intraperitoneal (IP) if no macroscopic residual tumor at the end of the intervention (initial or interval). If evidence of macroscopic residual tumor, cisplatin is administered in IV. Epirubicin is always given in IV.&#xD;
Second cytoreduction surgery at mid-term of chemotherapy cycles, only in patients operable in response after 3 cycles and with persistent residual disease after initial surgery or incomplete initial staging.&#xD;
The regimen of administration of the chemotherapy is as following:&#xD;
Cisplatin 80mg / m² - IV or IP - D1&#xD;
Epirubicin 60mg / m² - IV - D3&#xD;
one Cycle every 3 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CC0 - Carboplatin (IV) - Paclitaxel (IV)</intervention_name>
    <description>(6 cycles)</description>
    <arm_group_label>Control arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CC0 - Cisplatin (IP) - Epirubicin (IV)</intervention_name>
    <description>(6 cycles)</description>
    <arm_group_label>Experimental arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CC&gt;0 - Carboplatin (IV)- Paclitaxel (IV)</intervention_name>
    <description>carboplatin (IV) - paclitaxel (IV) (3 cycles)&#xD;
Interval surgery&#xD;
Carboplatin (IV) - paclitaxel (IV) (3 cycles)</description>
    <arm_group_label>Control arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CC&gt;0 - Cisplatin (IP/IV)- Epirubicin (IV)</intervention_name>
    <description>Cisplatin (IV) - Epirubicin (IV) (3 cycles)&#xD;
Interval surgery :&#xD;
if CC0: Cisplatin (IP) - Epirubicin (IV) (3 cycles)&#xD;
if CC&gt;0 Cisplatin (IV)- Epirubicin (IV) (3 cycles)</description>
    <arm_group_label>Experimental arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed advanced (FIGO stage III or IV) invasive epithelial ovarian&#xD;
             cancer, primary peritoneal cancer, or fallopian-tube cancer. Pleural cytology has to&#xD;
             be performed in patients with pleural effusion.&#xD;
&#xD;
          -  Initial intervention : debulking surgery or diagnostic surgery in the 3 weeks before&#xD;
             inclusion&#xD;
&#xD;
          -  Age ≥18 and &lt; 75 years old.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 before surgery (ECOG&#xD;
             ≤ 1 and Lee score &lt; 6 in patients &gt; 70 years old).&#xD;
&#xD;
          -  Adequate blood count (test realized in the past 14 days before inclusion) :&#xD;
             neutrophils &gt; 1500/mm3, platelets &gt; 150 000/mm3.&#xD;
&#xD;
          -  Creatinine clearance MDRD ≥ 60 mL/min&#xD;
&#xD;
          -  Registration in a national health care system (CMU included).&#xD;
&#xD;
          -  Signed and dated informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  FIGO stage IV extra-abdominal disease, with the exception of lymph nodes and pleural&#xD;
             invasion.&#xD;
&#xD;
          -  Patient having received previous chemotherapy for ovarian cancer.&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt; 50% before chemotherapy initiation&#xD;
&#xD;
          -  Other invasive cancer in the past 5 years (baso- and spinocellular cutaneous carcinoma&#xD;
             with complete resection are accepted)&#xD;
&#xD;
          -  Concomitant administration of prophylactic phenytoin or live attenuated viral vaccines&#xD;
             such as yellow fever vaccine,&#xD;
&#xD;
          -  Patients with known hypersensitivity to any component of study drug&#xD;
&#xD;
          -  Patients without motivation or capacity to respect study requirements and constraints&#xD;
&#xD;
          -  Pregnancy or breast feeding women&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard VILLET, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Groupe Hospitalier Diaconessess Croix Saint Simon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Richard VILLET, MD</last_name>
    <phone>33 (0) 1 44 74 10 42</phone>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Delphine COCHEREAU, MD</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Georges François Leclerc</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leïla BENGRINE, MD</last_name>
    </contact>
    <investigator>
      <last_name>Leïla BENGRINE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Hospitalier Franco-Britannique</name>
      <address>
        <city>Levallois-Perret</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aimery De GRAMONT, MD</last_name>
    </contact>
    <investigator>
      <last_name>Aimery De GRAMONT, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Delphine COCHEREAU, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Diaconesses Croix Saint Simon</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Richard VILLET, MD</last_name>
    </contact>
    <investigator>
      <last_name>Richard VILLET, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romain COHEN, MD</last_name>
    </contact>
    <investigator>
      <last_name>Romain COHEN, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Poissy Saint Germain</name>
      <address>
        <city>Poissy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cyrille HUCHON, MD</last_name>
    </contact>
    <investigator>
      <last_name>Cyrille HUCHON, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nadia RABAN</last_name>
    </contact>
    <investigator>
      <last_name>Nadia RABAN, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Senlis</name>
      <address>
        <city>Senlis</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elisabeth CAROLA, MD</last_name>
    </contact>
    <investigator>
      <last_name>Elisabeth CAROLA, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>February 10, 2021</last_update_submitted>
  <last_update_submitted_qc>February 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intraperitoneal</keyword>
  <keyword>Intravenous</keyword>
  <keyword>Completeness of cytoreduction score</keyword>
  <keyword>Carboplatin</keyword>
  <keyword>Epirubicin</keyword>
  <keyword>Paclitaxel</keyword>
  <keyword>Cisplatin</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>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Epirubicin</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/NCT03025477
org study id: RVT_2015_2
nct id: NCT03025477
lead sponsor: 
collaborator: 
has dmc: Yes
CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian
      advanced cancer.
This is a randomized phase II study, open-label and multicentric. After initial intervention
      (debulking surgery or diagnostic surgery) patient will randomized in the study according to
      Completeness of cytoreduction (CC) score (CC0 or CC>1).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pathological complete peritoneal response (pCR)
time frame: 2-year
description: Interval debulking surgery or final evaluation peritoneal surgery
measure: Quality of life (QLQ -C30) assessment
time frame: Up to 2-year (at inclusion, after 3 cycles and end of treatment)
measure: Quality of life (QLQ-OV28) assessment
time frame: Up to 2-year (at inclusion, after 3 cycles and end of treatment)
measure: IPSS score
time frame: Up to 2-year (at inclusion, after 3 cycles and end of treatment)
measure: Number of patients with treatment-related adverse events as assessed by CTCAE version 4.03
time frame: 2-year
measure: Event-free survival (EFS)
time frame: At 5-year and 10-year
measure: Objective response rate at the various surgical step
time frame: Up to 2-year
measure: Overall survival (OS)
time frame: At 5-year and 10-year
arm group label: Control arm
arm group type: Active Comparator
description: Initial or interval surgery associated with 6 cycles of chemotherapy in intravenous (IV) of carboplatin and paclitaxel.
The regimen of administration of the chemotherapy is as following:
Carboplatin AUC 6 - IV - Day (D) 1
Paclitaxel 80mg / m² - IV - D1, D8, D15
one cycle every 3 weeks
arm group label: Experimental arm
arm group type: Experimental
description: Initial or interval surgery associated with 6 cycles of chemotherapy of cisplatin and epirubicin.
Cisplatin is administrated in intraperitoneal (IP) if no macroscopic residual tumor at the end of the intervention (initial or interval). If evidence of macroscopic residual tumor, cisplatin is administered in IV. Epirubicin is always given in IV.
Second cytoreduction surgery at mid-term of chemotherapy cycles, only in patients operable in response after 3 cycles and with persistent residual disease after initial surgery or incomplete initial staging.
The regimen of administration of the chemotherapy is as following:
Cisplatin 80mg / m² - IV or IP - D1
Epirubicin 60mg / m² - IV - D3
one Cycle every 3 weeks.
intervention type: Drug
intervention name: CC0 - Carboplatin (IV) - Paclitaxel (IV)
description: (6 cycles)
arm group label: Control arm
intervention type: Drug
intervention name: CC0 - Cisplatin (IP) - Epirubicin (IV)
description: (6 cycles)
arm group label: Experimental arm
intervention type: Drug
intervention name: CC>0 - Carboplatin (IV)- Paclitaxel (IV)
description: carboplatin (IV) - paclitaxel (IV) (3 cycles)
Interval surgery
Carboplatin (IV) - paclitaxel (IV) (3 cycles)
arm group label: Control arm
intervention type: Drug
intervention name: CC>0 - Cisplatin (IP/IV)- Epirubicin (IV)
description: Cisplatin (IV) - Epirubicin (IV) (3 cycles)
Interval surgery :
if CC0: Cisplatin (IP) - Epirubicin (IV) (3 cycles)
if CC>0 Cisplatin (IV)- Epirubicin (IV) (3 cycles)
arm group label: Experimental arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Richard VILLET, MD
role: Principal Investigator
affiliation: Groupe Hospitalier Diaconessess Croix Saint Simon
last name: Richard VILLET, MD
phone: 33 (0) 1 44 74 10 42
last name: Delphine COCHEREAU, MD
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
mesh term: Cisplatin
mesh term: Carboplatin
mesh term: Epirubicin