Brain Metastases, Adult
Conditions
Keywords
limited brain metastases, small brain metastases, fractionated stereotactic radiotherapy
Brief summary
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.
Detailed description
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.
Interventions
The prescription is 30 Gy in 5 fractions.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The primary tumor is proved malignant by pathology; 2. Brain metastases are confirmed by enhanced MRI, and the number of lesions is 1-4; 3. The maximum diameter of each lesion is ≤ 2cm; 4. Age ≥ 18 years old; 5. KPS≥ 70; 6. Brain metastases haven't been previously treated locally and patients haven't received prior whole brain radiotherapy (WBRT); 7. expected survival of more than 6 months; 8. The functions of vital organs meet the requirements; 9. The patients voluntarily join the clinical study and sign the informed consent.
Exclusion criteria
1. Surgical intervention is considered for MDT consultation; 2. Meningeal metastasis; 3. The primary tumor is small cell lung cancer; 4. Follow-up data can't be obtained regularly; 5. patients are combined with other serious diseases, such as serious cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women); Patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) \< 50% indicated by color doppler examination; 6. neurological lesions such as cerebral hemorrhage and cerebral infarction occurred within 6 months; 7. Other circumstances that, in the investigator's judgment, would render the subject unfit for study enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| local control without symptomatic radiation necrosis rate | 1 year after fractionated stereotactic radiotherapy (FSRT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease control rate | 2 months after fractionated stereotactic radiotherapy (FSRT) | Complete release (CR) + partial release (PR) + stable disease (SD) rate, assessed by RECIST 1.1 criteria |
| local control rate | 1 year after fractionated stereotactic radiotherapy (FSRT) | local control rate of the lesions which received FSRT |
| intra-cranial distant failure rate | 1 year after fractionated stereotactic radiotherapy (FSRT) | new brain metastases in the brain |
| intra-cranial progression free survival rate | 1 year after fractionated stereotactic radiotherapy (FSRT) | local control without intra-cranial distant failure |
| adverse events | From date of fractionated stereotactic radiotherapy (FSRT) until the date of first documented progression, assessed up to 36 months. | neurological toxicity was determined according to RTOG acute toxicity classification criteria, and the rest was determined according to NCI-CTCAE V5.0 criteria |
| radiation necrosis rate | From date of fractionated stereotactic radiotherapy (FSRT) until the date of first documented progression, assessed up to 36 months. | 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYe Zhang, MD.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed