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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fractionated stereotactic radiotherapy group | Experimental | fractionated stereotactic radiotherapy is given to all the patients. The presciption is 30 Gy in 5 fractions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fractionated stereotactic radiotherapy | Radiation | The prescription is 30 Gy in 5 fractions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year after fractionated stereotactic radiotherapy (FSRT) |
| Measure | Description | Time Frame |
|---|---|---|
| disease control rate | Complete release (CR) + partial release (PR) + stable disease (SD) rate, assessed by RECIST 1.1 criteria | 2 months after fractionated stereotactic radiotherapy (FSRT) |
| local control rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ye Zhang, MD. | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ye Zhang | Beijing | Beijing Municipality | 100021 | China |
The IPD is protected by our institution and are not allowed to share to others.
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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local control rate of the lesions which received FSRT
| 1 year after fractionated stereotactic radiotherapy (FSRT) |
| intra-cranial distant failure rate | new brain metastases in the brain | 1 year after fractionated stereotactic radiotherapy (FSRT) |
| intra-cranial progression free survival rate | local control without intra-cranial distant failure | 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 | 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. | From date of fractionated stereotactic radiotherapy (FSRT) until the date of first documented progression, assessed up to 36 months. |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |