A Randomised Phase III Trial of Two Fractionation Schemes in the Treatment of Malignant Spinal Cord Compression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 5
- 主要终点
- Mobility status: measured by the change in mobility status between baseline and 5 weeks, as measured by the in-house mobility scale
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which radiation therapy schedule is more effective in treating patients with malignant spinal cord compression.
PURPOSE: This randomized phase III trial is studying two different radiation therapy schedules to compare their side effects and how well they work in treating patients with malignant spinal cord compression.
详细描述
OBJECTIVES:
Primary
- To compare the response in patients with malignant spinal cord compression treated with single fraction (10 Gy) radiotherapy vs standard multiple fraction (20 Gy) radiotherapy.
- To compare the toxicity of these treatment regimens in these patients.
Secondary
- Examine the safety, practicability, and efficacy of treatment with a single 10 Gy fraction of radiotherapy in these patients.
- Analyze the initial neurological status, document the response to treatment, and calculate median survival of these patients.
- Perform an economic impact analysis comparing the two treatment arms.
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
研究组 & 干预措施
Arm II
Patients undergo a single fraction of radiotherapy to the area of spinal cord compression (total of 10 Gy).
干预措施: radiation therapy (Radiation)
Arm I (control)
Patients undergo radiotherapy to the area of spinal cord compression once daily for 5 days (total of 20 Gy).
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Mobility status: measured by the change in mobility status between baseline and 5 weeks, as measured by the in-house mobility scale
时间窗: 5 weeks from date of randomisation
次要结局
- Toxicity: assessed at first follow-up, evaluated as per standard RTOG acute and long-term toxicity scale(1 week after completion of therapy)
- Quality of life as assessed by the EORTC QLQ-C30 version 3 quality-of-life questionnaire(5 weeks from date of randomisation)
- Overall survival: the survival duration will be calculated from time of randomisation to death whatever cause(Until death)
- Sphincter function: assessed using an 'In-House' Bladder Function Scale(Until death)
- Pain control: assessed using a Visual Analogue Scale(Until death)