Brain Metastases
Conditions
Interventions
9Gy*3f group:Stereotactic radiosurgery (SRS) for brain metastases,9 Gy per fraction delivered daily or every other day, to a total dose of 27Gy.
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years; 2.Histologically-confirmed extra-cranial solid primary malignancy; 3.Gadolinium-enhanced MRI demonstrating brain metastasis; 4.No prior cranial surgery or radiotherapy for the brain metastasis; 5.All lesions judged by the investigator to be amenable to stereotactic radiosurgery (SRS); 6.Karnofsky Performance Status (KPS) >= 70; 7.Extra-cranial disease stable and controlled for the preceding 3 months without radiologic progression; life expectancy >= 3 months; 8.Laboratory values meeting the following criteria: (1) Hematology: - Absolute neutrophil count >= 1,500/mm^³ (1.5 × 10^9/L) without growth-factor support within 14 days; - Platelet count >=100,000/mm³ (100 × 10^9/L) without transfusion or corrective therapy within 7 days; - Hemoglobin >=9.0 g/dL (90 g/L) without transfusion or corrective therapy within 7 days; (2) Chemistry: - Serum creatinine<= 1.5 × ULN or creatinine clearance = 60 mL/min; - Total bilirubin <=1.5 × ULN; - AST and ALT <=2.5 × ULN; 9.Voluntary participation with signed informed consent; anticipated good compliance with protocol requirements;
Exclusion criteria
Exclusion criteria: 1.Primary central nervous system tumors; 2.Brainstem or leptomeningeal metastases; 3.Contraindications to contrast-enhanced cranial MRI; 4.Dementia, anxiety disorders, or depression; 5.Intratumoral hemorrhage or hemorrhagic encephalopathy; 6.Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy, including active tuberculosis;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Local control rate; | — |
Countries
China
Contacts
Public ContactLi Guang
155 Nanjing North Street, Heping District, Shenyang, Liaoning, China
Outcome results
None listed