A Phase II Study to Evaluated the Long-term of Safety and Efficacy of Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors
Stereotactic Body Radiation Therapy(SBRT) for spinal metastases has been proved a good results in pain relieve and local control, However,the longterm of efficacy and safety of this regimen is unclear.The purpose of the study is to evaluate the longterm outcome of this therapeutic regimen in selective patients who will be survival more than 2 years.
• WHO scores 0-2;
• The primary lesion was confirmed by pathology or cytology;
• The metastatic lesions were diagnosed by imaging(CT,MRI,PET-CT,ECT),or the lesions were confirmed by biopsy;
• The metastatic lesion was limited in 3 consecutive vertebral bodies;
• The baseline pain score was ≥5(NRPS) and the use of analgesic drugs was recorded;
• The enhanced MRI scan of involved vertebral bodies was required in the 2 weeks before radiotherapy;
⁃ Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
• Leukocytes ≥ 3.0 x109/ L;
• Absolute neutrophil count (ANC) ≥ 1.5 x109/ L;
• Platelet count ≥ 100 x109/ L;
• Hemoglobin (Hb) ≥ 9g/ dL;
• Total bilirubin ≤1.5 x the upper limit of normal (ULN);
• Alanine aminotransferase (ALT) ≤ 3 x ULN;
• Aspartate aminotransferase (AST) ≤ 3 x ULN;
• Serum creatinine ≤ 1.5 x the ULN;
• Signed informed consent;