<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/NCT02247232</url>
  </required_header>
  <id_info>
    <org_study_id>Z100-01</org_study_id>
    <nct_id>NCT02247232</nct_id>
  </id_info>
  <brief_title>Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer</brief_title>
  <official_title>Randomized, Double-blind, Placebo-controlled Trial of Z-100 Plus Radiation Therapy in Patients With Locally Advanced Cervical Cancer - A Phase III Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zeria Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zeria Pharmaceutical</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a phase III, multicenter, double-blind, placebo-controlled, parallel group&#xD;
      comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical&#xD;
      cancer on radiotherapy. The study will use a central randomization with a dynamic allocation&#xD;
      using biased coin minimization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">February 25, 2022</completion_date>
  <primary_completion_date type="Actual">June 29, 2021</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5Years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">793</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Z-100</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Z-100</intervention_name>
    <arm_group_label>Z-100</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. FIGO stage (2008): IIIB, cervical cancer;&#xD;
&#xD;
          2. Pathologically confirmed squamous cell carcinoma of the cervix;&#xD;
&#xD;
          3. Patients with treatment-naive cervical cancer;&#xD;
&#xD;
          4. Patients without enlargement (≥15 mm in the short axis) in the lower abdominal&#xD;
             para-aortic lymph node confirmed by CT scanning (Patients need not repeat CT scan at&#xD;
             screening if CT data [film or electronic image] within 30 days before informed consent&#xD;
             are available and can be provided for central imaging assessment);&#xD;
&#xD;
          5. Patients ≥21, ≤79 years of age at informed consent;&#xD;
&#xD;
          6. Patients for whom it is considered possible to carry out intracavitary radiation in&#xD;
             radiotherapy;&#xD;
&#xD;
          7. Eastern Cooperative Oncology Group Performance Status: 0-2;&#xD;
&#xD;
          8. Patients with the following organ functions; (1) WBC ≥3,000/mm3; (2) Platelet count&#xD;
             ≥100,000/mm3; (3) Hemoglobin ≥9.5 g/dL (correction by blood transfusion is allowed);&#xD;
             (4) Total bilirubin ≤ three (3) times the upper limit of reference value at the&#xD;
             clinical testing laboratory; (5) AST, ALT ≤ three (3) times the upper limit of&#xD;
             reference value at the clinical testing laboratory; (6) Renal function:&#xD;
&#xD;
               1. If combination therapy with cisplatin is planned, creatinine clearance: ≥50&#xD;
                  mL/min;&#xD;
&#xD;
               2. If combination therapy with cisplatin is not planned, creatinine ≤ twice (2) the&#xD;
                  upper limit of reference value at the clinical testing laboratory;&#xD;
&#xD;
          9. Patients who are willing to give informed consents. &quot;&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keiichi Fujiwara, Prof,MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saitama Medical University International Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zeria Invetigative Sites</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zeria Investigative Sites</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zeria Investigative Sites</name>
      <address>
        <city>Kuala Lumpur</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zeria Investigative Sites</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zeria Investigative Sites</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zeria Investigative Sites</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zeria Investrigative Sites</name>
      <address>
        <city>Hanoi</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Singapore</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>March 3, 2022</last_update_submitted>
  <last_update_submitted_qc>March 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2022</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>Uterine Cervical Neoplasms</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/NCT02247232
org study id: Z100-01
nct id: NCT02247232
lead sponsor: 
has dmc: Yes
This study is a phase III, multicenter, double-blind, placebo-controlled, parallel group
      comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical
      cancer on radiotherapy. The study will use a central randomization with a dynamic allocation
      using biased coin minimization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Overall survival
time frame: 5Years
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: Z-100
arm group type: Experimental
intervention type: Drug
intervention name: Z-100
arm group label: Z-100
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 79 Years
healthy volunteers: No
last name: Keiichi Fujiwara, Prof,MD,PhD
role: Principal Investigator
affiliation: Saitama Medical University International Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
country: Korea, Republic of
country: Malaysia
country: Singapore
country: Taiwan
country: Thailand
country: Vietnam
responsible party type: Sponsor
mesh term: Uterine Cervical Neoplasms