Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors
Recruiting
Phase 2Interventional Study
Breast CancerProstate CancerNon Small Cell Lung Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
RenJi Hospital · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. WHO scores 0-2;
2. The primary lesion was confirmed by pathology or cytology;
3. The metastatic lesions were diagnosed by imaging(CT,MRI,PET-CT,ECT),or the lesions were confirmed by biopsy;
4. The metastatic lesion was limited in 3 consecutive vertebral bodies;
5. The baselin…
Inclusion Criteria:
1. WHO scores 0-2;
2. The primary lesion was confirmed by pathology or cytology;
3. The metastatic lesions were diagnosed by imaging(CT,MRI,PET-CT,ECT),or the lesions were confirmed by biopsy;
4. The metastatic lesion was limited in 3 consecutive vertebral bodies;
5. The baseline pain score was ≥5(NRPS) and the use of analgesic drugs was recorded;
6. 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:
1. Leukocytes ≥ 3.0 x109/ L;
2. Absolute neutrophil count (ANC) ≥ 1.5 x109/ L;
3. Platelet count ≥ 100 x109/ L;
4. Hemoglobin (Hb) ≥ 9g/ dL;
5. Total bilirubin ≤1.5 x the upper limit of normal (ULN);
6. Alanine aminotransferase (ALT) ≤ 3 x ULN;
7. Aspartate aminotransferase (AST) ≤ 3 x ULN;
8. Serum creatinine ≤ 1.5 x the ULN;
9. Signed informed consent;
Exclusion Criteria:
1. 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;
2. There were \>3 consecutive vertebral bodies involved;
3. Spinal cord compression has occurred;
4. The gap between tumor and spinal cord was less than 3mm;
5. The metastatic area previously received radiation;
6. Pregnant and Nursing women;
7. Uncontrolled co-morbid illnesses;
9.refused to signed informed consent;
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