Randomized Controlled Trial Comparing Conventional Radiotherapy With Stereotactic Body Radiotherapy in Patients With Bone Metastases - VERTICAL Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Complete or partial pain response after radiation, defined according to the International Bone Metastases Consensus Endpoints for Clinical Trials.
研究概览
简要总结
The purpose of the study is to investigate effectiveness of stereotactic body radiotherapy in patients with bone metastatic disease.
详细描述
Rationale: Bone metastases are a frequent distant manifestation of solid tumours, and many bone metastases are located in the spine. These patients mostly present with severe (back) pain which reduces quality of life. The primary treatment for pain management is a single-fraction low dose external beam radiation therapy (EBRT), effective in achieving pain reduction in around 60% of patients, of whom 0-23% experience complete pain response. Recently, there is growing evidence that Stereotactic Body Radiotherapy (SBRT) achieves a much higher pain response due to the higher dose administered. In retrospective and a few prospective case series, SBRT for spinal, and also non-spinal metastases has been demonstrated to be safe, and efficacious. However, no randomized controlled trials have been performed.
Objective: To study whether the pain response after three months in patients with osseous metastatic disease increases after SBRT in comparison to low dose EBRT.
Study design: Randomized controlled trial, the VERTICAL study, nested within the PRESENT cohort.
Study population: Eligible patients are MRI-compatible patients with radiographic evidence of bone metastases at the radiotherapy department. Fifty-five patients are recruited in both control and intervention arm.
Intervention: Patients will undergo MRI-based, cone beam CT-guided SBRT and will receive a single dose of 18 Gray (Gy) on the visible metastasis, and 8 Gy on the bony compartment containing the metastasis (e.g. the affected vertebra or pedicle).
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
- •Radiographic evidence of bone metastases
- •For spinal lesions; per lesion no more than 3 consecutive spine segments involved with one unaffected vertebral body above and below
- •No more than 2 painful lesions needing treatment
- •Histologic proof of malignancy
- •No compression of spinal cord
- •No or mild neurological signs (i.e. radiculopathy, dermatomal sensory change, and muscle strength of involved extremity is Medical Research Council (MRC) 4/5
- •Medically inoperable or patient refused surgery
- •Karnofsky performance score (KPS) > 50
- •Numeric rating scale (NRS) > 3
- •Age > 18 years
- •Written informed consent
- •Filling out PRESENT-questionnaires
排除标准
- •Lesion in C1 or C2
- •Radio-sensitive histology such as multiple myeloma, lymphoma, small cell, germ cell
- •Spinal MRI cannot be completed for any reason (in according with the MRI protocol of the Department of Radiology)
- •Impossible to delineate metastasis and organs at risk (OAR) due to artifacts on CT or MRI from previous surgical stabilization
- •Unable to undergo SBRT treatment, according to treating doctor's opinion
- •Epidural disease
- •Severe, worsening or progressive neurological deficit
- •Unstable lesion requiring surgical stabilization
- •Patient with < 3 months life expectancy
- •Previous EBRT or SBRT to same level
- •Chemotherapy or systemic radionuclide delivery within 24 hours before and after SBRT
结局指标
主要结局
Complete or partial pain response after radiation, defined according to the International Bone Metastases Consensus Endpoints for Clinical Trials.
时间窗: 3 months
The primary endpoint of this study is complete or partial pain response after SBRT or EBRT after three months. Complete and partial response, but also possible pain progression or indeterminate response, will be defined according to the International Bone Metastases Consensus Endpoints for Clinical Trials.
次要结局
- Health-Related Quality of Life(at 2, 4, 6, 8 weeks, 3 and 6 months, then every 6 months)
- Occurrence or progression of vertebral compression fracture (VCF)(up to 12 months)
- Progression free survival(up to 3 years)
- Occurrence of radiation-induced myelopathy(up to 12 months)
- Duration of pain relief(at 2, 4, 6, 8 weeks, 3 and 6 months)
- Overall survival(up to 3 years)
- Determination of rapidity of pain relief(at 2, 4, 6, 8 weeks, 3 and 6 months)