<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/NCT02250846</url>
  </required_header>
  <id_info>
    <org_study_id>WHXH-027</org_study_id>
    <nct_id>NCT02250846</nct_id>
  </id_info>
  <brief_title>Study of EGFR-TKI to Asymptomatic Brain Metastases of NSCLC</brief_title>
  <acronym>EABM</acronym>
  <official_title>Phase II Study of EGFR-TKI in Patients With EGFR Mutation Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wuhan Union Hospital, China</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether EGFR-TKI can control the development of&#xD;
      intracranial lesions in Non Small Cell Lung Cancer patients with asymptomatic brain&#xD;
      metastases, and the difference in progression free survival between exon 19 and exon 21&#xD;
      mutations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A open, positive control of phase II clinical trials, divided into selection period,&#xD;
      treatment period and follow-up period , comply with the standard set of participants signed a&#xD;
      written informed consent, according to different divided into 19 patients with EGFR mutations&#xD;
      outside show son mutation group) and 21 extra show mutations, and according to the ECOG&#xD;
      physical status, age, previous systemic treatments such as hierarchical analysis, regular&#xD;
      follow-up and to assess efficacy, life care and safety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">January 2017</completion_date>
  <primary_completion_date type="Anticipated">January 2016</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>Intracranial disease progression time</measure>
    <time_frame>20 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Asymptomatic Brain Metastases of Non Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>arm a</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EGFR exon 19 mutation with EGFR-TKI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>arm b</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EGFR exon 21 mutation with EGFR-TKI</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EGFR-TKI</intervention_name>
    <description>egfr-TKI treatment</description>
    <arm_group_label>arm a</arm_group_label>
    <arm_group_label>arm b</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. at the age of 18 -70 years old, male or female&#xD;
&#xD;
          2. the non-small cell lung cancer diagnosed by histopathology&#xD;
&#xD;
          3. detected by ARMS to confirm that the EGFR sensitive mutant patients&#xD;
&#xD;
          4. the existence of MRI diagnosis of intracranial metastatic head enhancement, and the&#xD;
             presence of imaging evaluating lesions (according to RECIST1.1)&#xD;
&#xD;
          5. have not received prior treatment of intracranial metastases, including radiotherapy,&#xD;
             gamma knife, chemotherapy drugs&#xD;
&#xD;
          6. no brain metastasis symptoms, including, increased intracranial pressure, no vomiting,&#xD;
             ignoring the papillary edema, no headache, without hemiplegia, ignore things not&#xD;
             clear, without epilepsy&#xD;
&#xD;
          7. PS:0 or 1&#xD;
&#xD;
          8. the expected survival time 3 months &amp;gt;&#xD;
&#xD;
          9. patients signed informed consent voluntarily&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. 4 weeks before entering the group received operation or operation, the wound has not&#xD;
             healed completely&#xD;
&#xD;
          2. into group 2 weeks before receiving immune therapy or treatment of traditional Chinese&#xD;
             Medicine&#xD;
&#xD;
          3. serious cardiovascular diseases, including Department of internal medicine,&#xD;
             uncontrolled hypertension, unstable angina, myocardial infarction history exists&#xD;
             within the past June, severe arrhythmia or pericardial effusion&#xD;
&#xD;
          4. serious infection, need intravenous antibiotic, antifungal or antiviral treatment&#xD;
&#xD;
          5. before entering the group 4 weeks participated in any study drug clinical trial&#xD;
&#xD;
          6. there are serious tumor invasion, oppression by the main bronchus or bronchial&#xD;
             stenosis or obstruction, superior vena cava syndrome&#xD;
&#xD;
          7. the existence of herniation of brain tumor apoplexy, epilepsy, and frequent&#xD;
&#xD;
          8. suffering from a mental illness, poor compliance&#xD;
&#xD;
          9. the researchers think that do not fit into the group of cases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 25, 2014</last_update_submitted>
  <last_update_submitted_qc>September 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wuhan Union Hospital, China</investigator_affiliation>
    <investigator_full_name>Gang Wu</investigator_full_name>
    <investigator_title>cancer center</investigator_title>
  </responsible_party>
  <keyword>EGFR mutations</keyword>
  <keyword>asymptomatic brain metastases</keyword>
  <keyword>EGFR-TKI</keyword>
  <keyword>Erlotinib</keyword>
  <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>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Brain 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/NCT02250846
org study id: WHXH-027
nct id: NCT02250846
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether EGFR-TKI can control the development of
      intracranial lesions in Non Small Cell Lung Cancer patients with asymptomatic brain
      metastases, and the difference in progression free survival between exon 19 and exon 21
      mutations.
A open, positive control of phase II clinical trials, divided into selection period,
      treatment period and follow-up period , comply with the standard set of participants signed a
      written informed consent, according to different divided into 19 patients with EGFR mutations
      outside show son mutation group) and 21 extra show mutations, and according to the ECOG
      physical status, age, previous systemic treatments such as hierarchical analysis, regular
      follow-up and to assess efficacy, life care and safety.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intracranial disease progression time
time frame: 20 months
arm group label: arm a
arm group type: Experimental
description: EGFR exon 19 mutation with EGFR-TKI
arm group label: arm b
arm group type: Experimental
description: EGFR exon 21 mutation with EGFR-TKI
intervention type: Drug
intervention name: EGFR-TKI
description: egfr-TKI treatment
arm group label: arm a
arm group label: arm b
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Wuhan Union Hospital, China
investigator full name: Gang Wu
investigator title: cancer center
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Neoplasm Metastasis
mesh term: Brain Neoplasms