Status:
COMPLETED
Icotinib Combined With WBRT For NSCLC Patients With Brain Metastases and EGFR Mutation
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
Non-small Cell Lung Cancer
Brain Metastases
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of Icotinib at different dose levels in combination with whole brain radiotherapy for NSCLC patients with brain metastases and EGFR...
Detailed Description
The long-term control of brain metastases becomes a clinical challenge. Whole brain radiotherapy, the standard treatment for patients with multiple brain metastases, can only bring a modest survival i...
Eligibility Criteria
Inclusion
- Histological or cytological confirmation of non-small cell lung cancer (NSCLC).
- Diagnosis of brain metastases on a Gadolinium-enhanced MRI. More than 3 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm.
- Positive EGFR mutation.
Exclusion
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01516983
Start Date
December 1 2011
End Date
December 1 2013
Last Update
February 17 2014
Active Locations (1)
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1
West China Hospital
Chengdu, Sichuan, China, 610041