<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/NCT01670890</url>
  </required_header>
  <id_info>
    <org_study_id>pumch-neurosurgery-01</org_study_id>
    <nct_id>NCT01670890</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas</brief_title>
  <official_title>Efficacy and Safety of Salvage Treatment With Dose-dense TMZ Plus CDDP in the Patients With Recurrent Malignant Gliomas: a Multicentre,Prospective Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Medical University General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Temozolomide is the standard adjuvant chemotherapy of newly-diagnosis malignant&#xD;
      gliomas.Cisplatin , a kind of chemotherapeutics, can enforce the anti-tumor effects of TMZ.&#xD;
      Up to now, the prognosis of recurrent gliomas is very pessimistic and the standard treatment&#xD;
      procedure has not been established yet.&#xD;
&#xD;
      The prospective,multicentre phase II clinical study is to evaluate the efficacy and safety of&#xD;
      TMZ and CDDP in patients with recurrent malignant gliomas&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <primary_completion_date type="Anticipated">August 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>over all survival</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression free survival</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Malignant Gliomas</condition>
  <arm_group>
    <arm_group_label>TMZ group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients were treated with TMZ alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TMZ plus CDDP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients were treated with TMZ plus CDDP</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TMZ</intervention_name>
    <description>patients were treated with TMZ alone,Oral TMZ 50mg/m2/day,day 1 to 28,for 6 cycles</description>
    <arm_group_label>TMZ group</arm_group_label>
    <other_name>temozolomide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TMZ plus CDDP</intervention_name>
    <description>patients were treated with TMZ plus CDDP,CDDP was administered iv from day 1 to 3 with the total dose of 100mg and TMZ was administered orally 50mg/m2/day,day 1 to 28,for 6 cycles</description>
    <arm_group_label>TMZ plus CDDP group</arm_group_label>
    <other_name>temozolomide and cisplatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Age&gt;=18 and &lt;=70years old&#xD;
&#xD;
          -  Histological diagnosis of malignant gliomas(WHO III or IV)&#xD;
&#xD;
          -  The status of methylation of promotor of MGMT should be detected.&#xD;
&#xD;
          -  The time to be enrolled should be more than 90 days after the irradiation.&#xD;
&#xD;
          -  The patients with recurrent gliomas were treated with non-dose-dense TMZ therapy&#xD;
             before enrollment.&#xD;
&#xD;
          -  Performance status(Karnofsky index)&gt;=60&#xD;
&#xD;
          -  Life expectancy more than 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ages:&lt; 18 years or &gt; 70 years&#xD;
&#xD;
          -  Abnormal function of liver or renal(value more than 1.5 fold normal upper limit )&#xD;
&#xD;
          -  Blood routing: Hb &lt; 100g/l， WBC &lt; 4.0×109/l; PLT &lt; 100×109/l&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Allergic to administered drugs&#xD;
&#xD;
          -  Radiation treatment in the previous 90 days or stereotactic radiation surgery within&#xD;
             60 days before enrollment&#xD;
&#xD;
          -  The patients with recurrent gliomas were treated with dose-dense TMZ therapy before&#xD;
             enrollment.&#xD;
&#xD;
          -  Life expectancy less than 3 months&#xD;
&#xD;
          -  Participation in other clinical trials in the 90previous days before enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>wang renzhi, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>wang renzhi, MD</last_name>
    <phone>86-010-69156071</phone>
    <email>wangrz@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wang yu, MD</last_name>
    <phone>86-010-69156071</phone>
    <email>kingrichwy@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Tiantan Hospital Affiliated to Capital Medial University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiang tao, MD</last_name>
      <phone>86-010-67021832</phone>
      <email>jiangtao369@sohu.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>wang ren zhi, MD</last_name>
      <phone>86-010-69156071</phone>
      <email>wangrz@126.com</email>
    </contact>
    <investigator>
      <last_name>Ma wen bin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>wang yu, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tianjin medical university general university</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yang xue jun, MD</last_name>
      <email>ydenny@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>August 21, 2012</last_update_submitted>
  <last_update_submitted_qc>August 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>temozolomide(TMZ)</keyword>
  <keyword>cisplatin(CDDP)</keyword>
  <keyword>recurrent malignant gliomas</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Temozolomide</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/NCT01670890
org study id: pumch-neurosurgery-01
nct id: NCT01670890
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Temozolomide is the standard adjuvant chemotherapy of newly-diagnosis malignant
      gliomas.Cisplatin , a kind of chemotherapeutics, can enforce the anti-tumor effects of TMZ.
      Up to now, the prognosis of recurrent gliomas is very pessimistic and the standard treatment
      procedure has not been established yet.

      The prospective,multicentre phase II clinical study is to evaluate the efficacy and safety of
      TMZ and CDDP in patients with recurrent malignant gliomas
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: over all survival
time frame: 1 year
measure: progression free survival
time frame: 6 months
arm group label: TMZ group
arm group type: Active Comparator
description: patients were treated with TMZ alone
arm group label: TMZ plus CDDP group
arm group type: Experimental
description: patients were treated with TMZ plus CDDP
intervention type: Drug
intervention name: TMZ
description: patients were treated with TMZ alone,Oral TMZ 50mg/m2/day,day 1 to 28,for 6 cycles
arm group label: TMZ group
other name: temozolomide
intervention type: Drug
intervention name: TMZ plus CDDP
description: patients were treated with TMZ plus CDDP,CDDP was administered iv from day 1 to 3 with the total dose of 100mg and TMZ was administered orally 50mg/m2/day,day 1 to 28,for 6 cycles
arm group label: TMZ plus CDDP group
other name: temozolomide and cisplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: wang renzhi, MD
role: Study Chair
affiliation: Peking Union Medical College Hospital
last name: wang renzhi, MD
phone: 86-010-69156071
email: wangrz@126.com
last name: Wang yu, MD
phone: 86-010-69156071
email: kingrichwy@126.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Glioma
mesh term: Cisplatin
mesh term: Temozolomide