Combining Intraoperative Radiotherapy With Kyphoplasty for Treatment of Spinal Metastases
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
The primary objective is to evaluate the tolerability (side effects) of the intraoperative radio therapy (IORT) (e.g., wound healing, infections, bone necrosis, nerve, spinal cord damage, and pathological fracture), and the secondary objective is to evaluate the effectiveness of IORT (i.e., pain relief, quality of life, narcotic use, and tumor response).
详细描述
Disease Background:
Bone metastases are the third most common site of metastatic spread, affecting 10% - 30% of all cancer patients. The spine remains the most common site of bone metastases, with incidence ranging from 30-70% depending on the primary tumour.
Spinal metastases can be a significant cause of morbidity for cancer patients: severe pain, bone fracture, nerve root or spinal cord compression, hypercalcemia, and limited mobility. Symptomatic spinal metastases are most frequently located in the thoracic spine (70%), followed by lumbar spine (20%) and cervical spine (10%). Up to 15% of all cancer patients with bone metastasis will suffer compression fracture leading to loss of function and the impairment of mobility, while more than 70% of the patients will experience severe cancer-related pain affecting quality of life. Newer systemic agents targeting specific pathway or molecule within the tumor milieu has led to a dramatic improvement in life expectancy for metastatic patients. Hence, effective palliative treatment options for spinal metastases is an important clinical issue in today's oncologic practice.
Current Practice:
The majority of patients with spinal metastases are initially managed medically with combination of analgesic medication, bisphosphonates, or biologic/chemotherapy agents.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic patients from solid tumor
- •Estimated life expectancy of at least 3 months
- •Age >= 50 years.
- •Karnofsky Performance Status >= 70%
- •Numeric Pain Intensity Score >= 3
- •10% or more loss of vertebrae height
- •Adequate organ and marrow function as defined below:
- •International normalized ratio (INR)/ prothrombin time (PT) within normal institutional limits
- •leukocytes >= 3,000 microliter (mcL)
- •Absolute neutrophil count >= 1,500 mcL
- •Platelets >= 100,000 mcl
- •Total bilirubin within normal institutional limits
- •Abnormal aspartate transaminase (AST or SGOT) or alanine transaminase (ALT or SPGT)
- •Abnormal creatinine
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •Patients who have had prior external beam radiotherapy or surgery in the area of planned intervention
- •Previous radiopharmaceuticals (i.e, Ra-222, Sr-90, etc) within 30 days of procedure
- •Patients who are receiving systemic therapy (chemotherapy, hormonal, immunotherapy, bisphosphonates, etc) or other investigational agents are eligible if the systemic therapy can be safely held two weeks prior to procedure. These therapies may be resumed two weeks after the procedure
- •Primary hematologic malignancies
- •Patients with clinical or radiographic evidence of spinal cord or cauda equine compression or effacement
- •Chronic vertebrae fracture of greater than 6 months or coexisting bilateral pedicle fracture
- •Previous kyphoplasty in the same area
- •Patients with severe spinal deformity requiring open reconstruction or extreme adiposity, in which determining placement of metal sleeve would be difficult by fluoroscopy (limited bone margin)
- •History of allergic reactions attributed to compounds of similar composition to agents used for kyphoplasty
- •Uncontrolled medical illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Pre-menopausal female
结局指标
主要结局
Pain
时间窗: 52 weeks
Patient will rate the severity of pain on a numeric 0-10 scale with higher scores indicating more severe pain. Pain assessment will be done at baseline, day of the procedure, and during follow up visits for up to 52 weeks.
次要结局
- Tumor Response(52 weeks)
研究者
Abhishek A. Solanki
Assistant Professor
Loyola University