NCT00310167已完成3 期
A Phase III Multi-Center Randomized Controlled Trial of Low-Dose Radiotherapy for Follicular Lymphoma and Marginal Zone Lymphoma
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 614
- 试验地点
- 2
- 主要终点
- Local progression-free interval in irradiated field
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. It is not yet known which regimen of low-dose radiation therapy is more effective in treating follicular non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two different regimens of low-dose radiation therapy (24Gy versus 4Gy) to compare how well they work in treating patients with follicular or marginal zone non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Compare the local progression-free interval in patients with follicular non-Hodgkin's lymphoma (NHL) treated with 2 different regimens of low-dose radiotherapy.
Secondary
- Compare acute toxicity at 4 weeks in patients treated with these regimens.
- Compare late toxicity in patients treated with these regimens.
- Compare tumor response at 12 weeks in patients treated with these regimens.
- Compare overall survival in patients treated with these regimens.
- Assess the health economics of these regimens in these patients.
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
4 Gy
Experimental
4 Gy in 2 fractions
干预措施: radiation therapy (Radiation)
24 Gy
Active Comparator
24 Gy in 12 fractions
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Local progression-free interval in irradiated field
时间窗: up to 5 years after randomisation
Time form randomisation to tumour progression within the irradiated field
次要结局
- Health economic assessment(up to 5 years after randomisation)
- Overall survival(up to 5 years after randomisation)
- Late toxicity(from 12 weeks after randomisation up to 5 years)
- Tumor response in irradiated area at 12 weeks after randomization(at 12 weeks after randomization)
- Acute toxicity(at 4 weeks after randomization)
研究者
研究点 (2)
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