<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/NCT01687439</url>
  </required_header>
  <id_info>
    <org_study_id>NSCLC0901</org_study_id>
    <nct_id>NCT01687439</nct_id>
  </id_info>
  <brief_title>Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer (NSCLC)</brief_title>
  <official_title>Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary objective: functional imaging and quantitative imaging detection of the effects of&#xD;
      Endostar combined with chemotherapy and radiotherapy on Non-small Cell Lung Cancer (NSCLC).&#xD;
&#xD;
      Secondary objective: To evaluate 1) the role of Endostar in regulating tumor vessels and&#xD;
      normalizing of microenvironment; 2) Toxicity of Endostar combined with chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2008</start_date>
  <completion_date type="Actual">October 2009</completion_date>
  <primary_completion_date type="Actual">October 2009</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>Tumor blood volume</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor blood flow</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Permeability-surface area product</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>18-FDG PET SUV values</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of adverse events</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible patients receive one cycle of Endostar monotherapy, two cycles of Endostar combined with chemotherapy (vinorelbine plus cisplatin) treatment, followed by Endostar plus radiotherapy treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Endostar</intervention_name>
    <description>7.5mg/m2, D1-14</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vinorelbine</intervention_name>
    <description>25-30mg/m2, D1,8</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>25 mg/m2, D1-3</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically proven inoperable stage IIIb-IV NSCLC&#xD;
&#xD;
          -  ECOG PS 0-1&#xD;
&#xD;
          -  Life expectancy &gt; 3 months&#xD;
&#xD;
          -  Adequate blood functions: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet&#xD;
             count ≥ 100 x 109/L, and hemoglobin ≥ 9 g / dL&#xD;
&#xD;
          -  Adequate liver function: total bilirubin &lt;1.5 times the upper limit of normal (ULN);&#xD;
             AST and ALT &lt;2.5 times ULN in patients without liver metastases, &lt;5 times ULN in&#xD;
             patients with liver metastases&#xD;
&#xD;
          -  Adequate renal function: serum creatinine ≤ 1.25 times ULN or calculated creatinine&#xD;
             clearance ≥ 50 mL / min and urinary protein &lt;2+. In patients with baseline urinary&#xD;
             protein ≥ 2+, 24 hours urine should be collected and 24 hours urine protein ≤ 1g&#xD;
&#xD;
          -  International normalized ratio (INR) ≤ 1.5 and prothrombin time(PT) ≤ 1.5 times ULN&#xD;
             within 7 days before enrollment&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of bleeding diathesis or coagulopathy&#xD;
&#xD;
          -  History of hemoptysis, defined as bright red blood more than half a teaspoon 3 months&#xD;
             before enrollment&#xD;
&#xD;
          -  Previously received chemotherapy and radiotherapy and biological targeted therapy&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic blood pressure&gt; 150 mmHg and/or diastolic blood&#xD;
             pressure&gt; 100 mm Hg)&#xD;
&#xD;
          -  Clinically significant (ie, active) cardiovascular diseases, such as cerebrovascular&#xD;
             accident (within 6 months before initiating treatment), myocardial infarction (within&#xD;
             6 months before initiating treatment), unstable angina, congestive heart failure (New&#xD;
             York Heart Association class ≥Grade II) , serious arrhythmia which needs medication&#xD;
             during the study and may affect the study or can not be controlled by drugs&#xD;
&#xD;
          -  Unhealed wounds, active peptic ulcer or fracture&#xD;
&#xD;
          -  Gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess&#xD;
             within 6 months before enrollment&#xD;
&#xD;
          -  Women with intact uterus (menopause more than two years excluded) who are unwilling to&#xD;
             take effective non-hormonal contraception (IUD, spermicide barrier birth control&#xD;
             device or sterilization) during the study. Male who are unwilling to take effective&#xD;
             contraceptive measures during the study&#xD;
&#xD;
          -  Participated in other clinical trials within 28 days before the initiation of&#xD;
             treatment.&#xD;
&#xD;
          -  Allergic to any of the study drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guoliang Jiang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ming Fan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>September 18, 2012</last_update_submitted>
  <last_update_submitted_qc>September 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Fan Ming</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vinorelbine</mesh_term>
    <mesh_term>Endostar protein</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/NCT01687439
org study id: NSCLC0901
nct id: NCT01687439
lead sponsor: 
has dmc: No
Primary objective: functional imaging and quantitative imaging detection of the effects of
      Endostar combined with chemotherapy and radiotherapy on Non-small Cell Lung Cancer (NSCLC).

      Secondary objective: To evaluate 1) the role of Endostar in regulating tumor vessels and
      normalizing of microenvironment; 2) Toxicity of Endostar combined with chemotherapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tumor blood volume
time frame: 3 months
measure: Tumor blood flow
time frame: 3 months
measure: Permeability-surface area product
time frame: 3 months
measure: 18-FDG PET SUV values
time frame: 3 months
measure: The incidence of adverse events
time frame: 3 months
arm group label: Treatment
arm group type: Experimental
description: Eligible patients receive one cycle of Endostar monotherapy, two cycles of Endostar combined with chemotherapy (vinorelbine plus cisplatin) treatment, followed by Endostar plus radiotherapy treatment.
intervention type: Drug
intervention name: Endostar
description: 7.5mg/m2, D1-14
arm group label: Treatment
intervention type: Drug
intervention name: Vinorelbine
description: 25-30mg/m2, D1,8
arm group label: Treatment
intervention type: Drug
intervention name: Cisplatin
description: 25 mg/m2, D1-3
arm group label: Treatment
intervention type: Radiation
intervention name: Radiotherapy
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guoliang Jiang, MD
role: Principal Investigator
affiliation: Fudan University
last name: Ming Fan, MD
role: Principal Investigator
affiliation: Fudan University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Fan Ming
investigator title: Associate Professor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Vinorelbine
mesh term: Endostar protein