Status:
UNKNOWN
Study of EGFR-TKI to Asymptomatic Brain Metastases of NSCLC
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Asymptomatic Brain Metastases of Non Small Cell Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 differ...
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 cons...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2017
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02250846
Start Date
January 1 2015
End Date
January 1 2017
Last Update
September 26 2014
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