This Phase II study is to determine the efficacy and safety of MR-Linac Guided Adaptive fractionated stereotactic radiotherapy (FSRT) in patients with brain metastases in non-small cell lung cancer.
This Phase II study is to determine the efficacy and safety of MR-Linac Guided Adaptive fractionated stereotactic radiotherapy (FSRT) in patients with brain metastases in non-small cell lung cancer. Patients will receive FSRT (30Gy in 5 fractions) on the MR-Linac treatment machine. The primary end point is 1-year intracranial progression-free survival. The secondary end points are objective response rate, 1-y PFS, 1-y OS, perilesional edema of brain metastases, quality of life, safety of treatment, dose coverage of targets and dose to normal organs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
The FSRT was delivered using the Unity-based MR-Linac treatment machine, with a total dose of 30Gy in 5 fractions.
Hui Liu
Guangzhou, Guangdong, China
1-year intracranial progression-free survival
Time frame: 1 year
Objective response rate
Time frame: 2 months
1-year progression-free survival
Time frame: 1 year
1-year overall survival
Time frame: 1 year
Rate of participants with perilesional edema of brain metastases evaluated byT2-weighted MRI
Time frame: 1 year
Quality of life evaluated by EORTC quality of life questionnaire
Time frame: 1 year
Rate of patients with treatment-related adverse events evaluated by CTCAE v4.0
Time frame: 1 year
Dose coverage to targets
Time frame: 2 months
Dose to normal organs
Time frame: 2 months
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