Dose-Escalated Spine SbRT (DESSRT) for Localized Metastasis to the Spinal Column
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI)
研究概览
简要总结
This study is being done to determine the feasibility and tolerability of a novel regimen of spine stereotactic radiosurgery (SSRS). SSRS delivers high doses of radiation to tumors of the spine using precision techniques.
In standard medical care, conventional SSRS is delivered in only 1 or 2 treatments. When this treatment is delivered in only 1-2 treatments, a high dose is used which can increase the side effects of treatment. This study aims to test an alternative technique of delivering SSRS over 5 treatments. By delivering the radiation therapy over multiple treatments, the dose of radiation is less per treatment.
详细描述
Given the limitations with conventional external-beam radiotherapy, spine stereotactic radiosurgery was developed as an alternative treatment for localized spine metastasis. Stereotactic radiosurgery is an alternative treatment option to conventional palliative radiotherapy, which has gained acceptance over the last decade. Clinical experience with spine stereotactic radiosurgery has showed high rates of pain control and improvement in neurological function in patients with epidural compression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Zubrod Performance Status 0-2
- •Localized spine metastasis from a solid tumor from the C1 to L5 levels (a solitary spine metastasis, two separate spine levels, or up to 3 separate sites; each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies)
- •Patients with epidural extension are eligible as long as there is a ≥ 2 mm gap between the spinal cord and the edge of the epidural lesion
- •Paraspinal disease extension is allowed as long as it measures ≤ 5 cm in the greatest dimension and that it is contiguous with the spine metastasis
- •For patients enrolled in cohort 2, the minimum time to re-irradiation should be 6 months
- •Numerical Rating Pain Scale (NRPS) score of ≥ 5 at the index site(s) (as rated when the patient is not taking pain medication)
排除标准
- •Radiosensitive histologies (myeloma, lymphoma, germ cell tumors, small cell lung cancer)
- •Non-ambulatory patients
- •>50% loss of vertebral body height or spinal instability to due pathologic compression fracture
- •Frank spinal cord compression, spinal cord displacement, or epidural extension within 2 mm of the spinal cord
- •Rapid neurologic decline
- •Patients for whom an MRI of the spine is medically contraindicated
- •Pregnant women
结局指标
主要结局
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for Brief Pain Inventory (BPI)
时间窗: within 5 days of treatment completion
Assess the change in the feasibility and tolerability response of dose-escalated spine SBRT in patients with de novo or recurrent spine metastases with the Brief Pain Inventory questionnaire. The scale is from 0-10.
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for FACT-G
时间窗: within 5 days of treatment completion
4 scales: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items) and functional well-being (7 items). The FACT-G, developed by Cella, et al.20 is a five point patient self-rating scale (from "not at all" to "very much").
Change in response to spine Stereotactic Body Radiotherapy (SBRT) for EQ-5D-5L
时间窗: within 5 days of treatment completion
Consists of 5 items covering 5 dimensions including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on 3 levels including: 1=no problems; 2= moderate problems; and 3=extreme problems
次要结局
- Duration of pain response(12 months)
- Change in response over time for the FACT-G(baseline, 12 months)
- Functional Assessment of Cancer Therapy-General (FACT-G)(12 months, 24 months)
- Pain relief(3 months)
- EuroQol (EQ-5D-5L)(12 months, 24 months)
- Number of safety events(12 months)
- Pain response(12 months)
- Change in response over time for the EQ-5D-5L(baseline, 12 months)