Icotinib Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation
NCT ID: NCT03754530
Last Updated: 2018-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
162 participants
INTERVENTIONAL
2018-12-01
2021-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Icotinib
icotinib is administered orally three times per day. Until emerge the progression of the intracranial disease, then is given radiotherapy(\>3 with WBRT or \<=3 with SRS) after PD
Icotinib
orally three times per day
Icotinib plus radiation therapy
Standard whole brain radiotherapy (WBRT) is given with 30GY/10 times(\>3), or SRS(\<=3) plus concurrent icotinib, which was administered orally three times per day. Until the disease progresses.
Icotinib
orally three times per day
WBRT or SRS
\>3 with WBRT;\<=3 with SRS
Interventions
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Icotinib
orally three times per day
WBRT or SRS
\>3 with WBRT;\<=3 with SRS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological or cytological confirmation of EGRF positive sensitive mutation
* Diagnosis of brain metastases on a Gadolinium-enhanced MRI
Exclusion Criteria
* Previous usage of radiation with brain
* CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
18 Years
75 Years
ALL
No
Sponsors
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Betta Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Li jiancheng
Role: STUDY_DIRECTOR
Fujian oncology hospital
Central Contacts
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Other Identifiers
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2018-007-02
Identifier Type: -
Identifier Source: org_study_id
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