Efficacy of Dose Intensified Radiotherapy of Spinal Metastases of Solid Tumors by Dose Increased, Homogeneous Radiation of Vertebral Body and Simultaneous Application of Stereotactic Boost.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 155
- 试验地点
- 6
- 主要终点
- tumor control (time up to progression)
研究概览
简要总结
Spinal metastases indicate for an incurable course of disease. Local tumor control after palliative radiotherapy of spinal metastases (10x3 Gy, 1x8Gy) is between 61 to 81%. In 30% of patients, therapy fails locally within two years associated with further symptoms that are difficult to treat, because a further radiation of already radiated vertebra leads to a higher rate of myelitis. This trial aims to improve local tumor control and control of pain by radiotherapy with increase in total and single dose. Dose elevation is realized by simultaneous, integrated boost mediated by image-guided stereotactic radiotherapy (IGRT & hfSRT) and by elevation of elective dose in vertebral body with 12x3 Gy (standard: 10x3 Gy). Primary endpoint is local tumor control (time up to progression). Secondary endpoints are pain control associated with quality of live, severity of acute and chronic adverse effects and overall survival. It is planned to recruit a total number of 155 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •minimum age 18
- •expectance of life at least 6 months
- •Karnofsky-Score > 50
- •1-3 vertebral body metastases
- •Up to 5 other, macroscopic metastases
- •effective contraception
- •geographic reachability of patients
- •Signed study-specific consent form prior to therapy
- •no on-treatment participation on other trials
排除标准
- •initial required neurosurgical decompression
- •rapid, neurological deterioration
- •prior radiotherapy of region for planned radiation
- •conditions that preclude the application of magnetic resonance tomography
- •malignancy: multiple myeloma or lymphoma
- •technical conditions preclude stereotactic irradiation (technical limitations of device)
- •pregnant or nursing women
- •Fertile patients who refuse effective contraception during study treatment
- •persistent drug and/or alcohol abuse
- •patients that are not able or willing to behave according to study protocol
- •absent attendance for personal, disease related data storage and transfer
- •on-treatment participation on other trials
研究组 & 干预措施
dose intensified
hypofractionated 12x3 Gy + integrated boost 12x4 Gy
干预措施: hypofractionated 12x3 Gy + integrated boost 12x4 Gy (Radiation)
standard
hypofractionated 10x3 Gy
干预措施: hypofractionated 10x3 Gy (Radiation)
结局指标
主要结局
tumor control (time up to progression)
时间窗: up to progression (MR-imaging), max. 5 years after therapy
次要结局
- pain control(assessment 60 months after therapy)
- severity of acute and chronic adverse effects(acute: assessment up to 6 weeks after therapy; chronic: assessment up to 60 months after therapy or up to progression)
- overall survival(assessment 60 months after therapy or up to death)