Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Safety and adverse events (AEs)
研究概览
简要总结
To learn about the safety of a procedure called cord dose escalated spine stereotactic radiosurgery (CDE-SSRS) in patients with MESCC.
详细描述
Primary Objectives The primary protocol objectives are to establish the safety of CDE-SSRS alone in participants with MESCC. Specifically, we aim to maintain an RM risk no greater than 1%. RM will be defined as non-functional paresis per the McCormick score (i.e., Grade D).
Secondary Objectives Secondary objectives include pain control as measured by the Brief Pain Inventory, quality of life as measured by the EQ-5D, symptom burden as measured by the MDASI-SP, overall survival, toxicity, ambulatory rate and cost-effectiveness. LC will be defined radiographically with serial MRI scans by the study radiologist per SPINO criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Greater than or equal to 18 years old
- •Radiographically documented spinal metastasis on spine MRI within 4 weeks of registration
- •Proximity of spinal metastasis to spinal cord or cauda equina which precludes achieving a GTV Dmin of at least 14 Gy per the PI
- •All participants must be able to receive single fraction SSRS at the site of interest with 0.01 cc of the spinal cord receiving 14-16 Gy and/or 0.01 cc of the cauda equina receiving 18-20 Gy. The goal of treatment is to select the minimal dose to the organ at risk which will achieve a GTV Dmin of 14 Gy at the treating physician's discretion.
- •Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
- •All participants must be able to receive a single fraction spine radiosurgery at the designated site of interest to at least a dose of 18 Gy
- •All participants must have a vertebral level site of interest from C1 to S2
- •Signed informed consent
- •Diagnosis of cancer excluding ultra-radiosensitive histologies (see 4.2)
- •Motor strength ≥ 4 out of 5 in extremity or extremities affected by the level of cord compression
排除标准
- •Participants with ultra-radiosensitive histologies (lymphoma, multiple myeloma/plasmacytoma)
- •Prior history of radiation at the spinal site of interest
- •Inability to lie supine comfortably for ≥ 60 minutes
- •Progressive neurological deficits due to compression
- •Inability of obtain an MRI
- •Inability or refusal to undergo an MR simulation
- •No eligible for single fraction SSRS for any reason
- •Participants who are pregnant
研究组 & 干预措施
Stereotactic Radiosurgery
A non-invasive, non-surgical procedure that precisely delivers radiation to cancer on the spine while avoiding surrounding, healthy tissue.
干预措施: Stereotactic Radiosurgery (Radiation)
结局指标
主要结局
Safety and adverse events (AEs)
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点