Investigation of Optimal Radiotherapy Regimen and Type of Irradiation in Treatment of Painful Bone Metastasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 23
- 主要终点
- Pain Relief (response rate) at 4 weeks
研究概览
简要总结
Bone metastasis is one of the most frequent end complications of the cancer. Radiation therapy is the mainstay of treatment in this disease. Single fraction radiotherapy in both single and multiple bone metastasis is widely used, but optimization of the single dose fractionation is needed. Two different regimens of radiotherapy dose fractionation will be investigated in both single and multiple bone metastasis and endpoints will include pain relief as well as toxicity and quality of life.
详细描述
PROTOCOL SCHEMA
Group A Treatment of single site of painful bone metastasis:
Arm 1: 4 Gy single fraction; mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), >4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after > 4 weeks
Arm 2: 8 Gy single fraction, mandate first retreatment if moderate or severe pain persists or recurs (as measured by categorical pain scale or VAS greater than 50 mm), >4 weeks after initial RT) retreat with 8 Gy single fraction; second retreatment is optional if moderate or severe pain recurs (as measured by categorical pain scale or VAS greater than 50 mm), retreat with 8 Gy after > 4 weeks
Group B Treatment of multiple bone metastasis: lower hemibody radiotherapy (LHBI):
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
- •histological diagnosis of malignancy associated with radiological evidence of painful bone metastasis
- •If patients with two sites of pain requiring separate treatment are to be entered, the same randomized treatment option will be used for both sites, but response at each site will be scored and analyzed separately.
- •age > 18 years
- •anticipated remaining life of at least 12 weeks (3 months)
- •informed consent
排除标准
- •Primary histology myeloma
- •Sites of previous RT or previous radioisotope treatment
- •conditions or circumstances, which may interfere with treatment or follow-up
- •complicated bone metastasis (pathological fractures, metastatic spinal cord compression)
结局指标
主要结局
Pain Relief (response rate) at 4 weeks
时间窗: Up to 52 weeks
次要结局
- Onset and Duration of Pain Relief in Responders(Up to 52 weeks)
- Toxicity(Up to 52 weeks)
- Quality of Life(Up to 52 weeks)
- Rates of Pathological Fractures and Spinal Cord Compression(Up to 52 weeks)