The purpose of this study is to evaluate the efficacy of icotinib alone or in combination with radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. The primary endpoint is overall survival .
Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases, and most patients died due to the progression of brain metastases. Some research show that icotinib combined with radiation therapy can improve the efficiency of NSCLC with brain metastases, but there is still controversial about the timing of radiation therapy intervention . This study is a prospective, multi-center, randomized, controlled trial of icotinib combined with early intervention or late intervention radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. They will be treated with icotinib and divided into 2 groups. Group 1: the radiation therapy will start within 1 month after icotinib treatment; Group2: the patients will be treated with icotinib first, radiation therapy intervene if disease progress.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
296
125mg Tid/375mg per day
\>3 with WBRT/HA-WBRT/SMART or 1-3 with SRS
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGOverall Survival
Time frame: from date of randomization until the date of death, assessed up to 36 months.
Progression-free survival of intracranial lesions
Time frame: from date of randomization until the date of progression, assessed up to 10 months
disease control rate of intracranial lesions
Time frame: from date of randomization until the date of progression, assessed up to 18 months
Quality of life measured by FACT-L/LCS 4.0
measured by FACT-L/LCS 4.0
Time frame: from date of randomization until the date of death from any cause, assessed up to 36 months
Neurocognitive function changes measured by MMSE
measured by MMSE
Time frame: from date of randomization until the date of death from any cause, assessed up to 36 months
Observing acute and late toxicity assessed by CTCAE v4.0
Assessed by CTCAE v4.0
Time frame: from date of randomization until the date of death from any cause, assessed up to 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.