A Phase II Study to Evaluated the Long-term of Safety and Efficacy of Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The rate of relieve pain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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;
- •9.refused to signed informed consent;
研究组 & 干预措施
Phase II open lable Study
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.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
结局指标
主要结局
The rate of relieve pain
时间窗: One week after radiation to 2 years late
According to the Numerical Rating Pain Scale (NRPS)
次要结局
- The duration relieve pain(One week after radiation to 2 years late)
- The incidence of toxicity(One week after radiation to 2 years late)
- The degree of relieve pain(One week after radiation to 2 years late)