Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors
Recruiting · NCT03392233 · Interventional (participants receive a specific treatment) · Lead sponsor: RenJi Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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;
Where it is running
1 location listed.
- Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine - Shanghai, Shanghai Municipality, China