NCT07809672招募中不适用
Efficacy and Safety of Stereotactic Body Radiation Therapy for Spinal Metastases With Epidural Spinal Cord Compression (Bilsky Grade 1c-3): A Prospective, Multicenter, Single-Arm Phase II Study
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年9月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Local failure
研究概览
简要总结
This prospective, multicenter, single-arm phase II clinical trial is designed to enroll patients with spinal metastases classified as Bilsky grade 1c-3 who will receive stereotactic body radiation therapy (SBRT). The objective of this study is to assess the efficacy and safety of SBRT in the treatment of spinal metastases with epidural spinal cord compression (Bilsky grade 1c-3).
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
- •· Participants must be capable of understanding and voluntarily signing the written informed consent form;· Age ≥ 18 years;· (ECOG) performance status score ≤ 3;· The primary tumor is histologically or cytologically confirmed as a solid malignant tumor (excluding multiple myeloma, lymphoma, and germ cell tumors);· Has clear radiological evidence of spinal metastases;· Has acceptable spinal stability (Spinal Instability Neoplastic Score [SINS] ≤ 6, or between 7-12 but assessed as stable by surgical consultation), or has previous spinal instability that has been determined to be stable after surgical intervention;· Bilsky grade of spinal metastases confirmed by magnetic resonance imaging (MRI) as 1c-3;· Number of consecutive involved vertebral segments ≤ 3;· The involved vertebral level is above the conus medullaris;· Laboratory tests indicate adequate organ function.
排除标准
- •·Histologically confirmed primary spinal tumor or central nervous system disease;· Intramedullary lesions;· Prior radiotherapy to the same vertebral level;· Presence of contraindications to MRI examination;· Unable to lie flat for ≥ 30 minutes;· Presence of other severe comorbidities, such as uncontrollable cardiovascular disease, pulmonary disease, or other organ dysfunction, with poor overall health status and intolerance to treatment;· Pregnant or breastfeeding women;· Currently participating in other interventional clinical research treatments, or having received other investigational drugs or investigational device treatments within 4 weeks prior to the first treatment.
研究组 & 干预措施
stereotactic body radiation therapy
Experimental
SBRT for patients with spinal metastases and epidural spinal cord compression (Bilsky grade 1c-3)
干预措施: SBRT (Radiation)
结局指标
主要结局
Local failure
时间窗: The time from randomization to local failure assessed up to 12 months
defined as radiographic and/or clinical progression within the radiotherapy target volume.
次要结局
- OS(the time from randomization to death from any cause assessed up to 12 months)
研究者
研究点 (1)
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