Phase I Study of Feasibility of Single Session Spine Stereotactic Radiosurgery (SSRS) in the Primary Management of Patients With Inoperable, Previously Irradiated Metastatic Epidural Spinal Cord Compression (MESCC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Number of Occurrences of Paralysis Caused by Radiation Myelitis (RM)
研究概览
简要总结
The goal of this clinical study is to learn the feasibility of using a single session of radiation, known as spine stereotactic radiosurgery (SSRS), to treat metastatic epidural spinal cord compression.
详细描述
Spinal cord compression is often treated with surgery followed by radiation in small doses every day for a number of days. When a patient cannot or will not have surgery, radiation is given daily. With increased accuracy and precision, higher doses of radiation can be given in a single session. Giving a higher dose in a single session may increase the chance that the tumor will stop growing into the spinal canal and will prevent spinal cord injury. This study will also help to identify the tolerance of the spinal cord to radiation in a single session.
Spine Stereotactic Radiosurgery:
You will lie in the mold that was made for you for 45-120 minutes while you receive your radiation treatment.
Follow-up Visits:
You will have follow-up visits at Months 3 (+/-2 weeks ), 6 (+/-4 weeks), 9 (+/-4 weeks), 12 (+/-8 weeks), 18 (+/-8 weeks), and 24 (+/-8 weeks) and then every 6 months after that. At each follow-up visit:
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
- •Greater than or equal to 18 years old
- •Radiographically documented metastatic epidural compression on spine Magnetic resonance imaging (MRI) within 4 weeks of registration, defined radiographically, ranging from minimal canal compromise and thecal indentation to actual displacement of the spinal cord.
- •Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
- •Signed Informed consent for irradiation
- •Diagnosis of cancer including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors
- •Motor Strength >/= 4 out of 5 in extremity or extremities affected by the level of the spinal cord compression
- •Karnofsky performance status (KPS) >/= 40
- •Patients deemed to be inoperable due to patient refusal, by neurosurgical evaluation, or for any reason
- •1 prior course of spine radiotherapy to the current region of interest
排除标准
- •Prior irradiation of the site to be treated </= 3 months prior to registration
- •Inability to tolerate lying flat on treatment table for greater than 30 minutes.
- •Patients unable to undergo MRI of the spine
- •Patients who have previously received maximum cord tolerance of 45 Gy in 5 weeks conventional fractionation or similar biologically effective dose (BED) to the area of the spine to be treated. Below are the normalized BED at 2 Gy per fraction with alpha/beta=2 for spinal cord in commonly used fractionation schemes in previously irradiated patients. Conventional Radiotherapy (Normalized Biologically Effective Dose) 20 Gy in 5 fractions(30 Gy 2/2), 30 Gy in 10 fractions(37.5 Gy 2/2), 37.5 Gy in 15 fractions(42 Gy 2/2), 40 Gy in 20 fractions(40 Gy 2/2), 45 Gy in 25 fractions(43 Gy 2/2), 50 Gy in 25 fractions(50 Gy 2/2) following equation: nBED is calculated by dividing BED by (1 + d/a/b), where d is 2 Gy and for spinal cord late effect a/b is 2, and we describe the units as Gy 2/2 (i.e., Gy 2/2 = 2-Gy equivalent with a/b = 2)
- •Patients who are pregnant.
- •Patients who have cord compression from bone components or configuration
结局指标
主要结局
Number of Occurrences of Paralysis Caused by Radiation Myelitis (RM)
时间窗: Up to 12 months following radiation
Maximum acceptable Dmax will be that in which there are fewer RM events than TP events prior to 12 months and less than 2 RM events.
次要结局
未报告次要终点