Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

  • End date
    Dec 31, 2027
  • participants needed
  • sponsor
    RenJi Hospital
Updated on 22 January 2021
platelet count
neutrophil count
stereotactic body radiation therapy
pet/ct scan
kidney function test


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.


Recently,Stereotactic Body Radiation Therapy(SBRT) become an alternative regimen for spinal metastases due to it's high dose cover the metastatic lesion and low dose in the adjacent spinal cord which result in more efficacy and less toxicity. However,the longterm of efficacy and safety of this regimen is unclear because of shortly median survival among unselective spinal metastases.To our knowledge,the median survival of some favorite metastatic diseases will be more than two years if they received appropriate system therapy.these include hormones dependent brest cancer/prostate cancer,and EGFR mutation non-small cell lung cancer(NSCLC) ect.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.

Condition Malignant neoplasm of prostate, Prostate Cancer, Prostate Cancer, Early, Recurrent, Non-Small Cell Lung Cancer, Prostatic disorder, Prostate Disorders, Breast Cancer, Breast Cancer, Prostate Disorders, Prostate Cancer, Early, Recurrent, Breast Cancer Diagnosis, Prostate Cancer, breast carcinoma, prostate carcinoma, cancer, breast, nsclc, prostate cancers
Treatment stereotactic body radiation therapy
Clinical Study IdentifierNCT03392233
SponsorRenJi Hospital
Last Modified on22 January 2021


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

There were significant changes in the shape of the vertebral body (the height of the vertebral body was compressed 50%) or the vertebral body was unchanged but the volume of the dissolving bone was 50% and could lead to serious bone adverse events
There were >3 consecutive vertebral bodies involved
Spinal cord compression has occurred
The gap between tumor and spinal cord was less than 3mm
The metastatic area previously received radiation
Pregnant and Nursing women
Uncontrolled co-morbid illnesses
refused to signed informed consent
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