A Phase III International Randomized Trial Of Single Versus Multiple Fractions For Re-Irradiation Of Painful Bone Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 850
- 试验地点
- 24
- 主要终点
- Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether single-fraction (single-dose) re-irradiation therapy is as effective as multiple-fraction (many small doses of radiation therapy) re-irradiation therapy in relieving bone pain caused by bone metastases.
PURPOSE: This randomized phase III trial is studying single-dose radiation therapy to see if it works as well as multiple-dose radiation therapy in treating patients previously irradiated with painful bone metastases.
详细描述
OBJECTIVES:
Primary
- Compare pain relief in patients undergoing single-fraction vs multiple-fraction re-irradiation of painful bone metastases at 2 months after treatment.
Secondary
- Compare overall pain relief in patients treated with these regimens.
- Compare time to pain progression in patients treated with these regimens.
- Assess relationship between response to initial radiation and pain relief after re-irradiation in these patients.
- Compare changes in functional interference after re-irradiation using the Brief Pain Inventory in patients treated with these regimens.
- Compare quality of life of patients treated with these regimens (patients in Canada, France, the Netherlands, and patients registered through RTOG).
- Determine characteristics of non-responders (to both initial and re-irradiation) among patients treated with these regimens.
- Monitor the incidence of acute severe radiation-related side effects in patients treated with these regimens.
- Monitor the incidence of in-field pathological fractures and spinal cord compression in patients treated with these regimens.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment
时间窗: 2 months
The primary endpoint of this study is Overall Response Rate (complete response and partial response) at two months after the first fraction of re-irradiation. A complete response was defined as a Brief Pain Inventory worst-pain score of zero with no associated increase in daily oral morphine equivalent. A partial response was defined as pain that persisted after treatment, either with a worst-pain score reduction of 2 or more and no increase in daily oral morphine equivalent consumption, or no increase in pain and a reduction in daily oral morphine equivalent consumption of at least 25%.
次要结局
未报告次要终点