<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/NCT01669226</url>
  </required_header>
  <id_info>
    <org_study_id>V01-2009-03</org_study_id>
    <secondary_id>SGOG OV1</secondary_id>
    <nct_id>NCT01669226</nct_id>
  </id_info>
  <brief_title>First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer</brief_title>
  <acronym>AICE</acronym>
  <official_title>A Phase II,Randomized Study of an Addition Intraperitoneal Cisplatin and Etoposide to Standard First-line Therapy in Stage IIIC and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Gynecologic Oncology Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Gynecologic Oncology Group</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the role of an additional intraperitoneal&#xD;
      chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This exploratory trial is to compare the efficacy of sequential chemotherapy, intraperitoneal&#xD;
      chemotherapy followed by intravenous chemotherapy, versus intravenous chemotherapy alone in&#xD;
      the first-line therapy for ovarian cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">September 2015</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>12-month disease non-progression rate</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>up to 120 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completion rate of intraperitoneal chemotherapy.</measure>
    <time_frame>up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessments</measure>
    <time_frame>baseline; 4th week of intraperitoneal,chemotherapy, 6th cycle of intravenous chemotherpy, 3, 6, and 12 months after first-line chemotherapy.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>up to 120 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse effects</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 5 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">215</enrollment>
  <condition>Bulky Stage IIIC and IV Epithelial Ovarian Cancer</condition>
  <condition>Fallopian Tube Cancer</condition>
  <condition>Primary Peritoneal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Regimen B, PEip and TCiv therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regimen A: Standard TCiv therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IV paclitaxel plus carboplatin or docetaxel plus carboplatin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PEip (weekly) and TCiv</intervention_name>
    <description>IP: cisplatin 50mg/m2 and etoposide 100mg/m2, weekly, 4 times; 14 days later IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5</description>
    <arm_group_label>Regimen B, PEip and TCiv therapy</arm_group_label>
    <other_name>platinum</other_name>
    <other_name>VP 16</other_name>
    <other_name>taxane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TCiv</intervention_name>
    <description>IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5</description>
    <arm_group_label>Regimen A: Standard TCiv therapy</arm_group_label>
    <other_name>taxane</other_name>
    <other_name>platinum</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years to ≤ 75 years.&#xD;
&#xD;
          -  Epithelial ovarian cancer with pathology confirmed stage IIIc or IV, expect for lymph&#xD;
             node metastasis alone&#xD;
&#xD;
          -  Optimal cytoreductive surgery, including hysterectomy, bilateral&#xD;
             salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a&#xD;
             residual disease no more than 1cm&#xD;
&#xD;
          -  Available to receive intraperitoneal chemotherapy 5-10 days postoperative, or no more&#xD;
             than postoperative 14 days for those with bowel resection.&#xD;
&#xD;
          -  ECOG performance 0-2.&#xD;
&#xD;
          -  No more than 3 cycles of chemotherapy prior to surgery.&#xD;
&#xD;
          -  Laboratory testing within 7 days of registration: hematopoietic: absolute neutrophil&#xD;
             count greater than 1,500/mm3; Platelet count greater than 100,000/mm3. Hepatic:&#xD;
             bilirubin less than 1.25 times upper limit of normal (ULN); Bilirubin &lt; 2.0, SGPT less&#xD;
             than 2 times ULN. Renal: creatinine less than 1.6 mg/dL, OR creatinine clearance&#xD;
             greater than 40 mL/min.&#xD;
&#xD;
          -  Comply with intraperitoneal chemotherapy and follow-up.&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Low-malignant potential ovarian tumor.&#xD;
&#xD;
          -  Laboratory testing insufficiency. Hemoglobin &lt; 10 g/dL. Renal insufficiency with serum&#xD;
             creatinine &gt; 1.6.&#xD;
&#xD;
          -  Bone marrow dysfunction: absolute neutrophil count less than 1,500/mm3; Platelet count&#xD;
             less than 80,000/mm3.&#xD;
&#xD;
          -  Active infection.&#xD;
&#xD;
          -  Clinically significant gastrointestinal abnormalities.&#xD;
&#xD;
          -  Active coronary artery disease, cerebrovascular disease, restrictive or obstructive&#xD;
             pulmonary disease, or congestive heart failure.&#xD;
&#xD;
          -  Other condition that could interfere with provision of informed consent, compliance to&#xD;
             study procedures, or follow-up.&#xD;
&#xD;
          -  Prior invasive malignancies within the last 5 years showing activity of disease.&#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>Rongyu Zang, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Gynecologic Oncology Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongda Hospital Southeast University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suzhou Municipal Hospital</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuxi Cancer Hospital</name>
      <address>
        <city>Wuxi</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ren Ji Hospital Affiliated to Shanghai JiaoTong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Frist Maternity and Infant Hospital Affiliated to Tongji University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fudan University Cancer Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.ShanghaiGOG.org</url>
    <description>Shanghai Gynecologic Oncology Group</description>
  </link>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ovarian Cancer</keyword>
  <keyword>intraperitoneal chemotherapy</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>
    <mesh_term>Fallopian Tube Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Taxane</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/NCT01669226
org study id: V01-2009-03
secondary id: SGOG OV1
nct id: NCT01669226
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the role of an additional intraperitoneal
      chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.
This exploratory trial is to compare the efficacy of sequential chemotherapy, intraperitoneal
      chemotherapy followed by intravenous chemotherapy, versus intravenous chemotherapy alone in
      the first-line therapy for ovarian cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 12-month disease non-progression rate
time frame: 12 months
measure: Progression-free survival
time frame: up to 120 months
measure: Completion rate of intraperitoneal chemotherapy.
time frame: up to 6 months
measure: Quality of life assessments
time frame: baseline; 4th week of intraperitoneal,chemotherapy, 6th cycle of intravenous chemotherpy, 3, 6, and 12 months after first-line chemotherapy.
measure: Overall Survival
time frame: up to 120 months
measure: adverse effects
time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
arm group label: Regimen B, PEip and TCiv therapy
arm group type: Experimental
description: Weekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin
arm group label: Regimen A: Standard TCiv therapy
arm group type: Active Comparator
description: IV paclitaxel plus carboplatin or docetaxel plus carboplatin
intervention type: Drug
intervention name: PEip (weekly) and TCiv
description: IP: cisplatin 50mg/m2 and etoposide 100mg/m2, weekly, 4 times; 14 days later IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
arm group label: Regimen B, PEip and TCiv therapy
other name: platinum
other name: VP 16
other name: taxane
intervention type: Drug
intervention name: TCiv
description: IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
arm group label: Regimen A: Standard TCiv therapy
other name: taxane
other name: platinum
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Rongyu Zang, MD,PhD
role: Principal Investigator
affiliation: Shanghai Gynecologic Oncology Group
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
url: http://www.ShanghaiGOG.org
description: Shanghai Gynecologic Oncology Group
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Fallopian Tube Neoplasms
mesh term: Taxane