Local Radiofrequency Ablation Plus External Beam Radiation for the Treatment of Painful Thoracic and Lumbar Spine Tumors -SPARC
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in pain intensity
研究概览
简要总结
This study looks at how well a combination of treatments helps reduce pain in people with tumors in the middle and lower back (thoracic and lumbar spine). All participants receive the same treatment, which includes a procedure to stabilize the spine (kyphoplasty), radiofrequency ablation will be with the Osteocool system and radiation therapy. The goal is to see how effective this combined approach is at relieving pain.
The purpose of this study is to find out whether combining these three treatments provides better pain relief for patients with thoracic and lumbar spine tumors. This study is for adults who have cancer that has spread to the thoracic or lumbar spine and who report moderate to severe back pain (a pain score of 5 or higher on a 0-10 pain scale).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- •Subjects is willing and able to comply with study procedures based on the judgement of the investigator.
- •Age ≥ 18 years at the time of consent.
- •Life expectancy beyond completion of protocol intervention of at least 1 month and deemed appropriate for treatment based on multidisciplinary review and/or investigator discretion.
- •Metastatic thoracic or lumbar spine tumor. Tumor should be lytic or mixed lytic/blastic. Note: there does not need to be a fracture.
- •Patient reported back pain of ≥ 5 on a VAS scale
排除标准
- •Active infection requiring systemic therapy.
- •Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- •Is currently taking Avastin or anti-coagulant meds that cannot be held.
- •Is currently enrolled in a cancer related clinical trial.
研究组 & 干预措施
Metastatic thoracic or lumbar spine tumor
metastatic thoracic or lumbar spine tumor and reported back pain of ≥ 5 on a visual analog scale (VAS) assessments scale.
干预措施: kyphoplasty with Osteocool (Procedure)
结局指标
主要结局
Change in pain intensity
时间窗: Baseline and at 3 months (1 months after completion of radiotherapy)
Change in pain intensity will be measured using visual analog scale (VAS) assessments, from baseline (pre-therapy) to 1 month post completion of radiotherapy.
次要结局
- Presence of thoracic and lumbar spine tumors(at 3- and 6-months following procedure)
- Long term new or worsened vertebral body compression fracture(at 6 months following procedure)
- Retreatment of thoracic and lumbar spine tumor(at 6 months following procedure)
- Quality of life per Patient-Reported Outcomes version of the Common Terminology Criteria(Baseline and at 6 months following procedure)
- Pain level(Baseline and at 6 months following procedure)
- Readmission rate(Up to 6 months following procedure)
- Narcotic pain medication(Up to 6 months following procedure)
- Grade 2 or higher Adverse Events(Up to 1 month)