This is a single-center, open lable, single-arm phase II clinical study to evaluate the efficacy and safety of fractionated stereotactic radiotherapy (FSRT) in patients with 1-4 brain metastases with ≤2cm in diameter.
This study plans to enroll 48 patients with 1-4 brain metastases with ≤2cm in diameter. All of the patients will receive FSRT with the dose of 30 Gy in 5 fractions. The primary endpoint is local control rate of asymptomatic brain necrosis at 1 year. The secondary endpoints include disease control rate at 2 months, local control rate at 1 year, intra-cranial distant failure at 1 year, overall survival rate at 1 year, toxicities, radiation necrosis rate, etc.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
The prescription is 30 Gy in 5 fractions.
Ye Zhang
Beijing, Beijing Municipality, China
local control without symptomatic radiation necrosis rate
radiation necrosis (RN) is defined as: enhanced MRI after radiotherapy shows lace or irregular enhancement around the lesion, less enhancement in the center of T1-WI, high signal around the lesion of T2-WI, and no nodules of equal intensity or low intensity, and no obvious diffusion restriction in DWI sequences. RN can be diagnosed if the above brain MRI findings still exist after 3 months of re-xamination.
Time frame: 1 year after fractionated stereotactic radiotherapy (FSRT)
disease control rate
Complete release (CR) + partial release (PR) + stable disease (SD) rate, assessed by RECIST 1.1 criteria
Time frame: 2 months after fractionated stereotactic radiotherapy (FSRT)
local control rate
local control rate of the lesions which received FSRT
Time frame: 1 year after fractionated stereotactic radiotherapy (FSRT)
intra-cranial distant failure rate
new brain metastases in the brain
Time frame: 1 year after fractionated stereotactic radiotherapy (FSRT)
intra-cranial progression free survival rate
local control without intra-cranial distant failure
Time frame: 1 year after fractionated stereotactic radiotherapy (FSRT)
adverse events
neurological toxicity was determined according to RTOG acute toxicity classification criteria, and the rest was determined according to NCI-CTCAE V5.0 criteria
Time frame: From date of fractionated stereotactic radiotherapy (FSRT) until the date of first documented progression, assessed up to 36 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
radiation necrosis rate
radiation necrosis (RN) is defined as: enhanced MRI after radiotherapy shows lace or irregular enhancement around the lesion, less enhancement in the center of T1-WI, high signal around the lesion of T2-WI, and no nodules of equal intensity or low intensity, and no obvious diffusion restriction in DWI sequences. RN can be diagnosed if the above brain MRI findings still exist after 3 months of re-xamination.
Time frame: From date of fractionated stereotactic radiotherapy (FSRT) until the date of first documented progression, assessed up to 36 months.