This is a randomized, controlled, open-label, phase III trials. The main purpose of this study is to evaluate the effectiveness and safety of tumor treating felds (TTF) combined with stereotactic radiosurgery (SRS) in the treatment of brain metastases from non-small cell lung cancer (NSCLC) .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Tumor Treating Fields will be administered continuously with a planned ≥ 18 h per day.
Patients will be treated with the best known standard of care for NSCLC brain metastasis and undergo SRS alone.
Intracranial tumor progression-free survival (iPFS)
Defined as the time from randomization to the first occurrence of intracranial progression (according to RANO-BM criteria) or neurologic death, whichever occurred first.
Time frame: 3 years
Overall Survival (OS)
Defined as the time from the date of treatment until death due to any cause.
Time frame: 3 years
Objective response rate (ORR)
Defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR).
Time frame: 3 years
Time to neurocognitive failure
Time frame: 3 years
Rate of intracranial progression at 2, 4, 6, 8, 10, 12 months
Time frame: 3 years
Neurocognitive failure-free survival
Time frame: 3 years
Rate of decline in cognitive function
Time frame: 3 years
Number of participants with adverse events (AEs)
Adverse events will be defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with study treatments
Time frame: 3 years
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