Fractionated Stereotactic Radiotherapy for Limited Small Volume Brain Metastases

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.

Inclusion criteria

• The primary tumor is proved malignant by pathology;
• Brain metastases are confirmed by enhanced MRI, and the number of lesions is 1-4;
• The maximum diameter of each lesion is ≤ 2cm;
• Age ≥ 18 years old;
• KPS≥ 70;
• Brain metastases haven't been previously treated locally and patients haven't received prior whole brain radiotherapy (WBRT);
• expected survival of more than 6 months;
• The functions of vital organs meet the requirements;
• The patients voluntarily join the clinical study and sign the informed consent.

Exclusion criteria

• Surgical intervention is considered for MDT consultation;
• Meningeal metastasis;
• The primary tumor is small cell lung cancer;
• Follow-up data can't be obtained regularly;
• 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;
• neurological lesions such as cerebral hemorrhage and cerebral infarction occurred within 6 months;
• Other circumstances that, in the investigator's judgment, would render the subject unfit for study enrollment.