The aim of this study is to explore the efficacy and toxicity of icotinib combined with WBRT in treating patients with multiple brain metastases from NSCLC.
Brain metastases occur in 25-40% of patients with non-small cell lung cancer (NSCLC). It is one of the primary reasons resulting in treatment failure and the death. Whole-brain radiation therapy (WBRT) is the standard approach to the treatment of multiple brain metastases from NSCLC. Regardless of the treatment of brain metastases by WBRT combined with systemic chemotherapy,outcomes of NSCLC with brain metastases are still very poor. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the blood-brain barrier and show promising antitumor activity against brain metastases from NSCLC. Icotinib shows nearly the same effect as gefitinib in advanced NSCLC patients failed with chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients will receive whole brain radiotherapy therapy 30Gy over 10 fractions and icotinib will be administered at the beginning of whole brain radiotherapy in doses of 125 mg thrice per day until disease progression or undue toxicity.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
partial response rate of intracranial lesions
Partial response rate of intracranial lesions will be measured.
Time frame: 2 years
Progression-free survival
Progression-free survival will be evaluated
Time frame: 4 years
overall survival
Overall survival will be evaluated
Time frame: 4 years
partial response rate of extracranial lesions
Partial response rate of extracranial lesions will be evaluated
Time frame: 2 years
Health-related quality of life
Health-related quality of life will be measured
Time frame: 2 years
safety and tolerability
Safety and tolerability of Icotinib and whole brain radiotherapy will be monitored by evaluation of frequency,severity,and duration of treatment-emergent adverse events in all subjects
Time frame: 4 year
the relationship between Progression-Free Survival and EGFR mutation status
The relationship between Progression-Free Survival and EGFR mutation status will be evaluated.
Time frame: 4 years
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