Program SBRT Technique Implementation in Spinal Metastases Irradiation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Maximum Treatment-Related Adverse Event Grade Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Within 12 Months After Spine SBRT
研究概览
简要总结
Stereotactic body radiotherapy (SBRT) is a highly precise, image-guided radiotherapy technique delivering 1-5 high-dose fractions to spinal metastases. Compared with conventional radiotherapy, SBRT enables delivery of a higher biologically effective dose while maintaining high precision.
The Institute of Oncology Ljubljana initiated spinal SBRT treatments in 2017 and introduced an institutional SBRT spine protocol in 2019. As SBRT is technically demanding, strict adherence to standardized planning and delivery procedures is essential to ensure treatment quality and patient safety.
This clinical program aims to support structured implementation and continuous development of the institutional SBRT spine protocol in routine clinical practice. The study prospectively evaluates treatment-related toxicity and local tumor control following SBRT for spinal metastases in order to monitor treatment safety and effectiveness within the institutional program.
详细描述
This clinical program supports the structured implementation and continuous development of stereotactic body radiotherapy (SBRT) for spinal metastases at the Institute of Oncology Ljubljana.
The program includes prospective peer review of target delineation and treatment plans, structured educational activities for involved staff, and continuous quality assurance procedures to maintain protocol adherence and treatment standardization. Retrospective review of previously delivered SBRT plans may be performed to evaluate consistency with institutional protocol standards.
All enrolled patients receive SBRT according to the institutional SBRT spine protocol. Clinical evaluation focuses on treatment-related toxicity assessed using standardized criteria and on radiological local tumor control during follow-up. Toxicity is evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), and local control is assessed using routine radiological imaging.
All collected data are anonymized. Participation in the study does not involve additional interventions, procedures, or risks beyond standard SBRT treatment and routine clinical follow-up.
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
- •Adult patients (≥18 years) with spinal metastases or spinal tumors referred for stereotactic body radiotherapy (SBRT).
- •Patients eligible for SBRT treatment according to the institutional SBRT spine protocol.
- •Ability to undergo CT simulation, immobilization, and image-guided radiotherapy procedures.
排除标准
- •Inability to tolerate SBRT positioning or immobilization.
- •Clinical situations requiring urgent surgical intervention or alternative treatment.
- •Other medical conditions that prevent safe SBRT delivery.
研究组 & 干预措施
SBRT for Spinal Metastases
Participants with spinal tumors or spinal metastases receive stereotactic body radiotherapy (SBRT) according to the institutional SBRT spine protocol. The implementation programme includes standardized workflow, regular SBRT educational workshops, protocol updates, image-guided radiotherapy verification, and prospective peer review of target delineation and treatment plans. Treatment outcomes including toxicity and local control are monitored prospectively
干预措施: Stereotactic Body Radiotherapy (SBRT) for Spinal Metastases (Procedure)
结局指标
主要结局
Maximum Treatment-Related Adverse Event Grade Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Within 12 Months After Spine SBRT
时间窗: From start of SBRT treatment up to 12 months after SBRT
Maximum treatment-related adverse event grade per patient within 12 months after stereotactic body radiotherapy (SBRT) for spinal metastases, assessed using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 grading scale.
次要结局
- Incidence of Grade 3 or Higher Treatment-Related Adverse Events Assessed by CTCAE Version 5.0(From start of SBRT treatment up to 12 months after SBRT)