A Phase 2 interventional study of Stereotactic Body Radiation Therapy in Breast Cancer, Prostate Cancer and Non Small Cell Lung Cancer, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-01-05.
Sponsored by RenJi Hospital · Phase 2, Interventional, and Treatment
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.
Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
Exclusion Criteria:
9.refused to signed informed consent;
Eligible patients will receive Stereotactic body radiation therapy (SBRT) for spinal metastatic lesion in 24Gy/3f(cervical vertebra) or 30Gy/3f (thoracic vertebra/lumbar vertebra) every other day and receive relevant system treatment at same time.
Radiation: Stereotactic Body Radiation Therapy
Eligible patients will receive Stereotactic body radiation therapy (SBRT) for spinal metastatic lesion in 24Gy/3f(cervical vertebra) or 30Gy/3f (thoracic vertebra/lumbar vertebra) every other day and receive relevant system treatment at same time
The rate of relieve pain
According to the Numerical Rating Pain Scale (NRPS)
Time frame: One week after radiation to 2 years late
The degree of relieve pain
According to the Numerical Rating Pain Scale (NRPS)
Time frame: One week after radiation to 2 years late
The duration relieve pain
According to the Numerical Rating Pain Scale (NRPS)
Time frame: One week after radiation to 2 years late
The incidence of toxicity
Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Time frame: One week after radiation to 2 years late
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RenJi Hospital