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Study of EGFR-TKI to Asymptomatic Brain Metastases of NSCLC (EABM)

Primary Purpose

Asymptomatic Brain Metastases of Non Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
EGFR-TKI
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asymptomatic Brain Metastases of Non Small Cell Lung Cancer focused on measuring EGFR mutations, asymptomatic brain metastases, EGFR-TKI, Erlotinib

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. at the age of 18 -70 years old, male or female
  2. the non-small cell lung cancer diagnosed by histopathology
  3. detected by ARMS to confirm that the EGFR sensitive mutant patients
  4. the existence of MRI diagnosis of intracranial metastatic head enhancement, and the presence of imaging evaluating lesions (according to RECIST1.1)
  5. have not received prior treatment of intracranial metastases, including radiotherapy, gamma knife, chemotherapy drugs
  6. no brain metastasis symptoms, including, increased intracranial pressure, no vomiting, ignoring the papillary edema, no headache, without hemiplegia, ignore things not clear, without epilepsy
  7. PS:0 or 1
  8. the expected survival time 3 months >
  9. patients signed informed consent voluntarily

Exclusion Criteria:

  1. 4 weeks before entering the group received operation or operation, the wound has not healed completely
  2. into group 2 weeks before receiving immune therapy or treatment of traditional Chinese Medicine
  3. serious cardiovascular diseases, including Department of internal medicine, uncontrolled hypertension, unstable angina, myocardial infarction history exists within the past June, severe arrhythmia or pericardial effusion
  4. serious infection, need intravenous antibiotic, antifungal or antiviral treatment
  5. before entering the group 4 weeks participated in any study drug clinical trial
  6. there are serious tumor invasion, oppression by the main bronchus or bronchial stenosis or obstruction, superior vena cava syndrome
  7. the existence of herniation of brain tumor apoplexy, epilepsy, and frequent
  8. suffering from a mental illness, poor compliance
  9. the researchers think that do not fit into the group of cases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    arm a

    arm b

    Arm Description

    EGFR exon 19 mutation with EGFR-TKI

    EGFR exon 21 mutation with EGFR-TKI

    Outcomes

    Primary Outcome Measures

    Intracranial disease progression time

    Secondary Outcome Measures

    Full Information

    First Posted
    September 22, 2014
    Last Updated
    September 25, 2014
    Sponsor
    Wuhan Union Hospital, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02250846
    Brief Title
    Study of EGFR-TKI to Asymptomatic Brain Metastases of NSCLC
    Acronym
    EABM
    Official Title
    Phase II Study of EGFR-TKI in Patients With EGFR Mutation Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    January 2016 (Anticipated)
    Study Completion Date
    January 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wuhan Union Hospital, China

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asymptomatic Brain Metastases of Non Small Cell Lung Cancer
    Keywords
    EGFR mutations, asymptomatic brain metastases, EGFR-TKI, Erlotinib

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    arm a
    Arm Type
    Experimental
    Arm Description
    EGFR exon 19 mutation with EGFR-TKI
    Arm Title
    arm b
    Arm Type
    Experimental
    Arm Description
    EGFR exon 21 mutation with EGFR-TKI
    Intervention Type
    Drug
    Intervention Name(s)
    EGFR-TKI
    Intervention Description
    egfr-TKI treatment
    Primary Outcome Measure Information:
    Title
    Intracranial disease progression time
    Time Frame
    20 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: at the age of 18 -70 years old, male or female the non-small cell lung cancer diagnosed by histopathology detected by ARMS to confirm that the EGFR sensitive mutant patients the existence of MRI diagnosis of intracranial metastatic head enhancement, and the presence of imaging evaluating lesions (according to RECIST1.1) have not received prior treatment of intracranial metastases, including radiotherapy, gamma knife, chemotherapy drugs no brain metastasis symptoms, including, increased intracranial pressure, no vomiting, ignoring the papillary edema, no headache, without hemiplegia, ignore things not clear, without epilepsy PS:0 or 1 the expected survival time 3 months > patients signed informed consent voluntarily Exclusion Criteria: 4 weeks before entering the group received operation or operation, the wound has not healed completely into group 2 weeks before receiving immune therapy or treatment of traditional Chinese Medicine serious cardiovascular diseases, including Department of internal medicine, uncontrolled hypertension, unstable angina, myocardial infarction history exists within the past June, severe arrhythmia or pericardial effusion serious infection, need intravenous antibiotic, antifungal or antiviral treatment before entering the group 4 weeks participated in any study drug clinical trial there are serious tumor invasion, oppression by the main bronchus or bronchial stenosis or obstruction, superior vena cava syndrome the existence of herniation of brain tumor apoplexy, epilepsy, and frequent suffering from a mental illness, poor compliance the researchers think that do not fit into the group of cases

    12. IPD Sharing Statement

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    Study of EGFR-TKI to Asymptomatic Brain Metastases of NSCLC

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