<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/NCT02972320</url>
  </required_header>
  <id_info>
    <org_study_id>CLOG1601</org_study_id>
    <nct_id>NCT02972320</nct_id>
  </id_info>
  <brief_title>Extensive Stage Sclc Patients Who Were Benefit From First-line Treatment Accept Temozolomide Maintain Therapeutic</brief_title>
  <official_title>Lobaplatin Combined With Etoposide for First-line Treatment in Extensive Stage Sclc Then Benefit Patients Follow up Temozolomide Maintain Therapeutic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yunpeng Liu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates temozolomide maintain therapeutic efficacy and safety in extensive stage&#xD;
      SCLC who has clinical benefit from etoposide combined Los platinum (EL) scheme in the first&#xD;
      line treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the etoposide combined Los platinum (EL) plan administration, every cycle was 21&#xD;
      days, a total of four cycle. The patients who was clinical benefit directly from EL scheme in&#xD;
      the first line treatment accept temozolomide maintenance therapy, 150mg / m2, oral D1-5. A&#xD;
      period of 28 days, regular follow-up and evaluation of effectiveness, safety and quality of&#xD;
      life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-Free Survival in the first line of chemotherapy</measure>
    <time_frame>6 months</time_frame>
    <description>The first day of treatment to the date that disease progression is reported</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>3 years</time_frame>
    <description>The first day of treatment to death or last survival confirm date</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor Response Rate (RR)</measure>
    <time_frame>3 months</time_frame>
    <description>The ratio between the number of responders and number of patients assessable for tumor response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-related adverse events</measure>
    <time_frame>the first date of treatment to 30 days after the last dose of study drug, assessed up to 6 months</time_frame>
    <description>Treatment-related adverse events are assessed by common terminology criteria for adverse events (CTCAE) V4.0.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Extensive Stage Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>temozolomide maintain therapeutic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lobaplatin combined with etoposide for first-line treatment of extensive stage small cell lung cancer,then clinical benefit patients for temozolomide maintain therapeutic.This study have only one arm which temozolomide maintain at dose of 150mg/m2 D1-5 Q4W.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>temozolomide</intervention_name>
    <description>temozolomide maintain therapeutic</description>
    <arm_group_label>temozolomide maintain therapeutic</arm_group_label>
    <other_name>Temozolomide Capsule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. aged 18 to 70 years old, men and women are not limited;&#xD;
&#xD;
          2. confirmed by histopathological examination SCLC;&#xD;
&#xD;
          3. clinical stage for patients with extensive stage (except for the case of pleural&#xD;
             effusion)&#xD;
&#xD;
          4. patients has no drug treatment history&#xD;
&#xD;
          5. the implementation of palliative radiotherapy for metastatic lesions, surgical&#xD;
             treatment, after the end of treatment over 14 days.&#xD;
&#xD;
          6. there can be measured lesions (non radiation exposure site) of patients (RECIST)&#xD;
             evaluation;&#xD;
&#xD;
          7. physical condition score ECOG PS:0-1&#xD;
&#xD;
          8. more than expected survival time over 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. the previous platinum compounds have a history of allergies;&#xD;
&#xD;
          2. active ulcer patients;&#xD;
&#xD;
          3. Patients with primary lung lesions were treated with radiotherapy;&#xD;
&#xD;
          4. chest X-ray showed clear interstitial pneumonia or patients with pulmonary fibrosis;&#xD;
&#xD;
          5. the need for treatment of brain metastases in the active phase&#xD;
&#xD;
          6. there are more serious tumor invasion, superior vena cava syndrome, or in the middle&#xD;
             volume of malignant pleural effusion, abdominal effusion or pericardial effusion, not&#xD;
             yet control;&#xD;
&#xD;
          7. there is a serious infection, ADH abnormal secretion syndrome, poor control of&#xD;
             diabetes,the need for the treatment of patients with severe complications such as vena&#xD;
             cava syndrome&#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_contact>
    <last_name>mingfang zhao, professor</last_name>
    <phone>13644055129</phone>
    <email>zhaomf618@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The First Affiliated Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>mingfang zhao, professor</last_name>
      <phone>13644055129</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>China Medical University, China</investigator_affiliation>
    <investigator_full_name>Yunpeng Liu</investigator_full_name>
    <investigator_title>Director, clinical research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Temozolomide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02972320
org study id: CLOG1601
nct id: NCT02972320
lead sponsor: 
has dmc: Yes
This study evaluates temozolomide maintain therapeutic efficacy and safety in extensive stage
      SCLC who has clinical benefit from etoposide combined Los platinum (EL) scheme in the first
      line treatment.
According to the etoposide combined Los platinum (EL) plan administration, every cycle was 21
      days, a total of four cycle. The patients who was clinical benefit directly from EL scheme in
      the first line treatment accept temozolomide maintenance therapy, 150mg / m2, oral D1-5. A
      period of 28 days, regular follow-up and evaluation of effectiveness, safety and quality of
      life.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-Free Survival in the first line of chemotherapy
time frame: 6 months
description: The first day of treatment to the date that disease progression is reported
measure: Overall Survival (OS)
time frame: 3 years
description: The first day of treatment to death or last survival confirm date
measure: Tumor Response Rate (RR)
time frame: 3 months
description: The ratio between the number of responders and number of patients assessable for tumor response.
measure: Treatment-related adverse events
time frame: the first date of treatment to 30 days after the last dose of study drug, assessed up to 6 months
description: Treatment-related adverse events are assessed by common terminology criteria for adverse events (CTCAE) V4.0.
arm group label: temozolomide maintain therapeutic
arm group type: Experimental
description: Lobaplatin combined with etoposide for first-line treatment of extensive stage small cell lung cancer,then clinical benefit patients for temozolomide maintain therapeutic.This study have only one arm which temozolomide maintain at dose of 150mg/m2 D1-5 Q4W.
intervention type: Drug
intervention name: temozolomide
description: temozolomide maintain therapeutic
arm group label: temozolomide maintain therapeutic
other name: Temozolomide Capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: mingfang zhao, professor
phone: 13644055129
email: zhaomf618@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: China Medical University, China
investigator full name: Yunpeng Liu
investigator title: Director, clinical research
mesh term: Small Cell Lung Carcinoma
mesh term: Temozolomide
sharing ipd: No