An interventional study of fractionated stereotactic radiotherapy in Brain Metastases, Adult, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Not applicable, Interventional, and Treatment
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 515 are open to participants now.
This study's enrollment of 33 is below the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 373 studies on the registry; 270 are open to participants now.
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Exclusion Criteria:
fractionated stereotactic radiotherapy is given to all the patients. The presciption is 30 Gy in 5 fractions.
Radiation: fractionated stereotactic radiotherapy
The prescription is 30 Gy in 5 fractions.
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.
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.
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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences