Fractionated Stereotactic Radiotherapy for Limited Small Volume Brain Metastases

Fractionated Stereotactic Radiotherapy for Limited Small Brain metastases--a Phase II Trial

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.

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.