A Pilot Study to Assess the Safety and Efficacy of Preoperative Stereotactic Body Radiotherapy for the Treatment of Metastatic Disease in Bone Requiring Surgical Stabilization
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 39
- 试验地点
- 7
- 主要终点
- risk of major wound complications
研究概览
简要总结
The purpose of this study is to test the safety of stereotactic body radiation therapy (SBRT) followed by surgical stabilization within 1 week. All participants will have metastatic cancer in the bone (bone metastases), and they will be at risk of pathologic fracture (broken bone caused by a disease). Another purpose of this study is to see if the treatment approach of SBRT followed by surgical stabilization within 1 week prevents cancer from returning to the bone.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of metastatic cancer with radiologic evidence of skeletal metastases
- •Treatment target involving humerus, radius, pelvis, sacrum, femur, or tibial diaphysis
- •Age at enrollment ≥18 years
- •Life expectancy >3 months
- •Ability to tolerate radiation simulation and treatment with immobilization of involved anatomic site
- •Surgical candidate, as determined by the treatment team
- •Ability to obtain informed consent from patient or legally authorized representative in the setting of patient with impaired decision-making capacity.
- •Must agree to practice an effective contraceptive method (for those with reproductive potential)
排除标准
- •Prior radiotherapy to the treatment site
- •Prior surgery involving the treatment site
- •Tumor volume or distribution precluding effective SBRT
- •Expected skin dose at the operative site ≥9 Gy
- •Imminently impending fracture requiring immediate stabilization surgery
- •Involvement of proximal tibia
- •Autoimmune connective tissue disorder
- •Administration of radiosensitizing medication 3 days before, during, and 3 days after RT
- •Active infection
- •Absolute neutrophil count <1.0
- •Pregnancy
研究组 & 干预措施
Preoperative Stereotactic Body Radiotherapy (SBRT)
Target lesions will be treated with preoperative SBRT consisting of biologically effective dose (BED10) of 50.4 - 81.6 Gy delivered in either three fractions or a single fraction. Active sparing of the intended surgical approach will be incorporated into the radiation plan by creating an avoidance structure. Surgical stabilization will proceed within 1 week of completion of radiotherapy. Pathologic specimens will be obtained intraoperatively via existing surgical access for histologic and molecular analysis. An optional research MRI with perfusion will be performed within 30 days prior to radiation simulation and within one-week after radiation therapy using 3T scanner. If patients receive radiation simulation at a non-MSK Manhattan site, MRI with Perfusion will not be performed.
干预措施: Preoperative Stereotactic Body Radiotherapy (SBRT) (Radiation)
结局指标
主要结局
risk of major wound complications
时间窗: 6 weeks after preoperative SBRT
Major wound complications are defined as reoperation for wound revision, clinically diagnosed surgical site infection, readmission for wound care, or prolonged (\>3 weeks postoperatively) active wound care.
次要结局
- rate of local control(1 year)