<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/NCT01724801</url>
  </required_header>
  <id_info>
    <org_study_id>CTONG1201</org_study_id>
    <nct_id>NCT01724801</nct_id>
  </id_info>
  <brief_title>Icotinib or Whole Brain Irradiation in EGFR-mutant Lung Cancer</brief_title>
  <acronym>BRAIN</acronym>
  <official_title>Phase III Study of Icotinib Treat the Patient With Brain Metastasis EGFR-mutant Non Small Cell Lung Cancer Comparing With Whole Brain Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Association of Clinical Trials</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guangdong Association of Clinical Trials</source>
  <brief_summary>
    <textblock>
      EGFR-TKI is good for the patients with EGFR-mutant non-small cell lung cancer.We design this&#xD;
      clinical trail to confirm if the efficacy of Epidermal Growth Factor Receptor Tyrosine Kinase&#xD;
      Inhibitor(EGFR-TKI )(ICOTINIB) is better than whole brain irradiation for the patient with&#xD;
      EGFR-mutant non-small cell lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      no available&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 14, 2012</start_date>
  <completion_date type="Actual">September 14, 2016</completion_date>
  <primary_completion_date type="Actual">June 30, 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>iPFS</measure>
    <time_frame>18 months</time_frame>
    <description>intracranial progression-free survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>progress-free survival (PFS)</measure>
    <time_frame>up to 16 months</time_frame>
    <description>progress-free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time of controlling brain metastasis symptom</measure>
    <time_frame>18months</time_frame>
    <description>time of controlling brain metastasis symptom</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate of brain metastasis</measure>
    <time_frame>12months</time_frame>
    <description>Response rate of brain metastasis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>18months</time_frame>
    <description>Cognitive function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival(OS)</measure>
    <time_frame>24months</time_frame>
    <description>overall survival(OS)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Toxicity</measure>
    <time_frame>24months</time_frame>
    <description>adverse events(according to CTC4.0)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">176</enrollment>
  <condition>Brain Metastasis</condition>
  <condition>Non Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>icotinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>icotinib administered orally at a dose of 125 mg 3 times daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Whole brain irradiation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Whole brain irradiation 30Gy/3Gy/10 fractions plus concurrent or sequential chemotherapy for 4-6 cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>whole brain radiation(WBI)</intervention_name>
    <description>WBI (30Gy/3Gy/10 fractions) plus concurrent or sequential chemotherapy for 4-6 cycles</description>
    <arm_group_label>Whole brain irradiation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Icotinib</intervention_name>
    <description>administered orally at a dose of 125 mg 3 times daily</description>
    <arm_group_label>icotinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient who was confirmed stage IV NSCLC with EGFR activating mutation and brain metastases&#xD;
        by pathologic histology or cytology.&#xD;
&#xD;
        Patient who brain metastases was shown in MRI or CT scan. Brain metastases lesions should&#xD;
        be more than 3.The diameter among these lesions should be more than 1 centimeter.&#xD;
&#xD;
        Males or females aged ≥18 years, &lt; 75 years. Eastern Cooperative Oncology Group(ECOG)&#xD;
        performance status 0-1. Life expectancy ≥12 weeks. The therapy of&#xD;
        surgery,chemotherapy,radiotherapy that the patients were ever received should be more than&#xD;
        2 weeks ago.The patient had recovered from the treatment.&#xD;
&#xD;
        Males and females should be contraceptive during the period of the trial until 8 weeks&#xD;
        after the last administration of icotinib.&#xD;
&#xD;
        Able to comply with the required protocol and follow-up procedures, and able to receive&#xD;
        oral medications.&#xD;
&#xD;
        Written informed consent provided.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient was received irradiation of brain. Patient with meningeal metastases were confirmed&#xD;
        by MRI or cytology test of cerebrospinal fluid.&#xD;
&#xD;
        Patient is received the treatment of Phenytoin, carbamazepine, rifampicin, phenobarbital,&#xD;
        or St. John's Wort.&#xD;
&#xD;
        Patient was received EGFR Tyrosine Kinase Inhibitor or EGFR monoclonal antibody.&#xD;
&#xD;
        Interstitial pneumonia.Pericardial effusion, pleural effusion is uncontrolled .&#xD;
&#xD;
        Any unstable systemic disease (including active infection, uncontrolled hypertension,&#xD;
        unstable angina, congestive heart failure, myocardial infarction within the previous year,&#xD;
        serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).&#xD;
&#xD;
        Any significant ophthalmologic abnormality ,especially severe dry eye syndrome&#xD;
        ,keratoconjunctivitis sicca,Sjogren syndrome,severe exposure keratitis or any other&#xD;
        disorder likely to increase the risk of corneal epithelial lesions.&#xD;
&#xD;
        Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome,&#xD;
        or inability to take oral medication, or have active peptic ulcer disease.&#xD;
&#xD;
        Female subjects should not be pregnant or breast-feeding. Adequate hematological function:&#xD;
        Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.&#xD;
&#xD;
        Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver&#xD;
        function :Total bilirubin £ 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase&#xD;
        (ALT )and Aspartate Aminotransferase (AST )&lt; 2.5 x ULN in the absence of liver metastases,&#xD;
        or &lt; 5 x ULN in case of liver metastases.&#xD;
&#xD;
        The symptoms of increased intracranial pressure are uncontrolled after dehydration and&#xD;
        cortisone treatment.&#xD;
&#xD;
        Patient need increase irradiation dose after routine irradiation(30GY/10f/2w) Patient&#xD;
        should treat extra cranial lesions first. Patient assessed by the investigator to be unable&#xD;
        or unwilling to comply with the requirements of the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jinji Yang, MD</last_name>
    <role>Study Director</role>
    <affiliation>Guangdong Provincial People's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guangdong General Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>February 28, 2017</last_update_submitted>
  <last_update_submitted_qc>February 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EGFR mutant</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT01724801
org study id: CTONG1201
nct id: NCT01724801
lead sponsor: 
collaborator: 
EGFR-TKI is good for the patients with EGFR-mutant non-small cell lung cancer.We design this
      clinical trail to confirm if the efficacy of Epidermal Growth Factor Receptor Tyrosine Kinase
      Inhibitor(EGFR-TKI )(ICOTINIB) is better than whole brain irradiation for the patient with
      EGFR-mutant non-small cell lung cancer.
no available
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: iPFS
time frame: 18 months
description: intracranial progression-free survival
measure: progress-free survival (PFS)
time frame: up to 16 months
description: progress-free survival
measure: time of controlling brain metastasis symptom
time frame: 18months
description: time of controlling brain metastasis symptom
measure: Response rate of brain metastasis
time frame: 12months
description: Response rate of brain metastasis
measure: Cognitive function
time frame: 18months
description: Cognitive function
measure: overall survival(OS)
time frame: 24months
description: overall survival(OS)
measure: Toxicity
time frame: 24months
description: adverse events(according to CTC4.0)
arm group label: icotinib
arm group type: Experimental
description: icotinib administered orally at a dose of 125 mg 3 times daily
arm group label: Whole brain irradiation
arm group type: Active Comparator
description: Whole brain irradiation 30Gy/3Gy/10 fractions plus concurrent or sequential chemotherapy for 4-6 cycles
intervention type: Radiation
intervention name: whole brain radiation(WBI)
description: WBI (30Gy/3Gy/10 fractions) plus concurrent or sequential chemotherapy for 4-6 cycles
arm group label: Whole brain irradiation
intervention type: Drug
intervention name: Icotinib
description: administered orally at a dose of 125 mg 3 times daily
arm group label: icotinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jinji Yang, MD
role: Study Director
affiliation: Guangdong Provincial People's Hospital
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Neoplasm Metastasis
mesh term: Brain Neoplasms
sharing ipd: Undecided