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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02250846
Recruitment Status : Unknown
Verified September 2014 by Gang Wu, Wuhan Union Hospital, China.
Recruitment status was:  Not yet recruiting
First Posted : September 26, 2014
Last Update Posted : September 26, 2014
Information provided by (Responsible Party):
Gang Wu, Wuhan Union Hospital, China

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.

Condition or disease Intervention/treatment Phase
Asymptomatic Brain Metastases of Non Small Cell Lung Cancer Drug: EGFR-TKI Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of EGFR-TKI in Patients With EGFR Mutation Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis
Study Start Date : January 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: arm a
EGFR exon 19 mutation with EGFR-TKI
egfr-TKI treatment

Experimental: arm b
EGFR exon 21 mutation with EGFR-TKI
egfr-TKI treatment

Primary Outcome Measures :
  1. Intracranial disease progression time [ Time Frame: 20 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Responsible Party: Gang Wu, cancer center, Wuhan Union Hospital, China Identifier: NCT02250846     History of Changes
Other Study ID Numbers: WHXH-027
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: September 26, 2014
Last Verified: September 2014

Keywords provided by Gang Wu, Wuhan Union Hospital, China:
EGFR mutations
asymptomatic brain metastases

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases