Randomized Trial of Vertebroplasty and Radiotherapy Versus Radiotherapy Alone for Osseous Spine Metastases
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Evaluation of pain relief with the Brief Pain Index (BPI), by a blind arm trial algologist, 3 months after radiotherapy.
研究概览
简要总结
A randomized phase III study of palliative external beam radiotherapy (RTOG 97-14) has shown that 8 Gy in a single fraction is very effective in providing pain relief, with complete or partial improvement in pain seen in 66% of patients with bone metastases. Percutaneous vertebroplasty (PV) is a technique designed to consolidate pathologic vertebral bodies through the injection of orthopaedic cement under fluoroscopic guidance. Consolidation provides rapid pain relief to painful vertebral body lesions secondary to osteoporosis, haemangiomas, myeloma and metastatic diseases, with complete or partial improvement in pain seen in 70-85% of patients. To date, no randomized trial has tested the association of vertebroplasty and radiotherapy to enhance pain relief for patients with painful osseous spine metastases.
A randomized trial has been designed to determine whether vertebroplasty and radiotherapy (8 Gy in a single fraction) provide enhancement pain and narcotic relief compared to radiotherapy alone for patients with painful osseous spine metastases
详细描述
Patients with 1 to 4 painful osseous spine metastases are randomized to 1 of 2 treatment arms:
- Arm 1: 8 Gy in a single fraction
- Arm 2: 8 Gy in a single fraction followed by vertebroplasty of the vertebral bodies, within 14 days after radiotherapy
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
- •Osseous spine metastases from squamous cell carcinoma or adenocarcinoma
- •One to four painful metastases located between the second cervical vertebra and the fifth lumbar vertebra
- •Moderate to severe pain
- •No spinal cord compression
- •Karnofsky performance status > 40
排除标准
- •Previous radiotherapy or surgery
- •Vertebral fracture or any other formal indication of stabilization of the rachis by surgery or vertebroplasty
- •Spinal cord compression
- •Known anomaly of the haemostasis, or needed anticoagulant treatment
结局指标
主要结局
Evaluation of pain relief with the Brief Pain Index (BPI), by a blind arm trial algologist, 3 months after radiotherapy.
时间窗: 3 months after radiotherapy
Response will be scored as complete (no pain), partial (improvement of < 2 points in BPI), stable (+/- 1 point change in BPI) or progressive (> 2 point worsening of BPI).
时间窗: during the study
Complete and partial responses will be considered treatment success, and stable and progressive responses will be considered treatment failures
时间窗: during the study
次要结局
- Evaluation of pain relief one month after radiotherapy(one month after radiotherapy)
- BPI-SF and EORTC QLQ-C30 will be used to assess general cancer quality of life.(during the study)
- The incidence of vertebral pathologic fracture will be registered.(one month after radiotherapy)