Phase II Study of Image-Guided Single Fraction SBRT With VMAT-FFF Technique for Vertebral Metastases
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Toxicity of single fraction SBRT on spine metastases using CTCAE v.4
研究概览
简要总结
Based on the known efficacy of ablative single dose SBRT and VMAT technique in various solid tumors, investigators have designed this study to assess feasibility of SBRT in selected patients with spine metastases.
详细描述
This is a prospective, phase 2 study. The main objectives are to assess acute and late side effects of single fraction SBRT for selected patients with vertebral metastases and to study the local control of disease in treated sites.
The schedule will be 1 fraction of 18 Gy delivered in one day with Volumetric Modulated Arc Therapy (VMAT) and Flattening filter-free (FFF) beams.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 ≥ 18years.
- •WHO performance status ≤ 2 (ECOG - KPS).
- •Histologically-proven of primary cancer disease.
- •Metastatic disease in the spine, from C1 to Sacrum. A maximum number of 5 sites. Each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies.
- •Epidural compression is eligible when there is at least 3 mm gap between the spinal cord and the edge of the epidural lesion, unless patient underwent decompression surgery.
- •A paraspinal mass ≤ 5 cm.
- •Minimal residual tumor after surgery
- •Metastases in other district of the body are allowed.
- •Informed consent.
排除标准
- •> 50% loss of vertebral body height.
- •Prior radiation to the interested spine.
- •Patients for whom an MRI of the spine is medically contraindicated.
- •Patients allergic to contrast used in MRIs or CT scans or who cannot be premedicated for the use of contrast.
结局指标
主要结局
Toxicity of single fraction SBRT on spine metastases using CTCAE v.4
时间窗: 1 year
Local control of the treated lesions using Kaplan-Meyer statistical curves
时间窗: 1 year
次要结局
- Pain control at treated sites after RT using CTCAE v.4(3 months)
- Difference of local and pain control between patients operated on vertebra and non-operated patients using CTCAE v.4(3 months)
- Local control of the metastatic disease using Kaplan-Meyer statistical curves(3 months)
- Overall survival of treated patients using Kaplan-Meyer statistical curves(1 year)
研究者
Michele Tedeschi
MD
Istituto Clinico Humanitas