SBRT of Liver Tumors and Metastases and Pancreatic Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Treatment Safety (Radiotherapy-Related Toxicity)
研究概览
简要总结
This prospective observational study evaluates the safety and effectiveness of stereotactic body radiotherapy (SBRT) for liver tumors, liver metastases, and pancreatic tumors. The study focuses on systematic monitoring and optimization of the SBRT treatment process, including adherence to the implemented protocol, with the aim of simplifying methods while maintaining treatment safety.
详细描述
Stereotactic body radiotherapy (SBRT) is an advanced radiotherapy technique that enables delivery of high radiation doses to tumors with high precision while limiting exposure of surrounding healthy tissues. This study prospectively follows patients treated with SBRT for primary liver tumors, liver metastases, and pancreatic tumors at the Institute of Oncology Ljubljana.
The primary aim is to monitor and optimize all steps of the SBRT workflow, including protocol adherence, in order to ensure safe implementation and to evaluate treatment outcomes. The study also aims to assess whether the established SBRT protocol can be simplified without compromising patient safety.
Treatment safety and effectiveness outcomes will be evaluated during follow-up, and the collected data will be used to support further refinement of SBRT procedures for upper gastrointestinal tumors
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
- •Age ≥ 18 years
- •Patients with liver tumors, liver metastases, or pancreatic tumors eligible for stereotactic body radiotherapy (SBRT)
- •Planned treatment with SBRT according to institutional protocol
- •Ability to comply with treatment and follow-up procedures
- •Signed informed consent
排除标准
- •Contraindications for SBRT according to institutional radiotherapy protocol
- •Prior radiotherapy that prevents safe SBRT delivery to the target region
- •Severe uncontrolled comorbidities preventing safe SBRT treatment
- •Pregnancy
- •Inability to provide informed consent or comply with study procedures
研究组 & 干预措施
SBRT Treatment
Patients with liver tumors, liver metastases, or pancreatic tumors treated with stereotactic body radiotherapy (SBRT) according to the institutional protocol.
干预措施: Stereotactic Body Radiotherapy (SBRT) (Radiation)
结局指标
主要结局
Treatment Safety (Radiotherapy-Related Toxicity)
时间窗: From start of SBRT up to 12 months after treatment
Assessment of acute and late treatment-related toxicity after stereotactic body radiotherapy (SBRT) for liver tumors, liver metastases, and pancreatic tumors, evaluated according to standard toxicity criteria.
次要结局
未报告次要终点