A Phase II Clinical Trial Evaluating the Efficacy of Combining Thermal Ablation and Spine Stereotactic Radiosurgery for Patients With Spine Metastases With Moderate to Severe Epidural Involvement

M.D. Anderson Cancer Center1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2016年8月29日最近更新: 2026年4月17日

适应症

干预措施

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方: M.D. Anderson Cancer Center
入组人数: 60
试验地点: 1
主要终点: Local tumor control rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This phase II clinical trial studies how well thermal ablation and spine stereotactic radiosurgery work in treating patients with cancer that has spread to the spine (spine metastases) and is at risk for compressing the spinal cord. Thermal ablation uses a laser to heat tumor tissue and helps to shrink the tumor by destroying tumor cells. Stereotactic radiosurgery delivers a large dose of radiation in a short time precisely to the tumor, sparing healthy surrounding tissue. Combining thermal ablation with stereotactic radiosurgery may be a better way to control cancer that has spread to the spine and is at risk for compressing the spinal cord.

详细描述

PRIMARY OBJECTIVE:

I. To document the rate of local control at 6 months in patients who receive a combination of thermal ablation and stereotactic spine radiosurgery (SSRS) for spine metastases with moderate to severe epidural involvement.

SECONDARY OBJECTIVES:

I. To determine local control at 1, 3, 9, 12, 18, and 24 months, and to compare to a historical control where patients received only SSRS at these time points and at 12 months.

II. To document the extent of epidural tumor regression at 1, 3, 6, 9, 12, 18 and 24 months.

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

•At least 18 years of age.
•Histologic diagnosis of solid malignant tumor (not one of the more radiosensitive histologic subtypes, see

排除标准

•), 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.
•Quantification of the degree of epidural spinal cord compression as grade 1C, 2, or 3 by MRI, with and without contrast sequences. Axial T2 sequence is encouraged but not required.
•The vertebral body site to be treated must be located from T2-T
•No more than 3 contiguous or discontiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session or 3 sessions.
•Motor strength >/=4 out of 5 in extremity or extremities affected by the level of the spinal cord compression (see section 4 for grading method).
•ECOG performance status </=2 or Karnofsky performance status (KPS) >/=50
•Life expectancy >3 months.
•Inoperable disease because of patient refusal, neurosurgical evaluation, or any other medical reasons.
•Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
•Prior conventional radiation to the same site is allowed as long as there is a greater than 3 months interval.
•All patients must sign informed consent forms verifying that they are aware of the investigational nature of this study in keeping with the rules and policies of MD Anderson Cancer Center. The only acceptable consent form is one approved by the MD Anderson institutional review board.
•Patients who do not have other options of treatment, based on consensus recommendation of the multidisciplinary spine SRS (SSRS) tumor board. Patients will have an appropriate medical oncologist for their disease.
•Primary tumors of radiosensitive histology (lymphoma, multiple myeloma, small cell carcinoma, germ cell tumors), as conventional radiation is likely to be effective in such cases.
•Prior conventional irradiation of the spine site and level to be treated with an interval shorter than 3 months.
•Lesions located outside of the spinal segments of T2 to T
•Prior surgery to the same levels of spine.
•Inability to lie flat on a treatment table for >60 minutes.
•Unable to undergo MRI of the spine
•Pregnancy (because radiation has the potential for teratogenic or abortifacient effects).
•Frank cord compression or cord compression from bone components or configuration and acute neurological deficits (defined as motor strength <4/5 in extremity or extremities affected by the level of the spinal cord compression).