NCT05543070招募中2 期
Low-dose Radiotherapy in Indolent Lymphoma：A Multi-center Phase II Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Rate of clinical complete response after radiotherapy
研究概览
简要总结
The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of low-dose radiotherapy (3 Gy*4f) in indolent lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathology proved iNHL
- •ECOG PS ≤3
- •Signed Informed consent
排除标准
- •History of radiotherapy at the same site
- •Primary malignant lymphoma of the gastrointestinal tract
- •CTV (Clinical Target Volume)>500ml
- •Others that researchers consider inappropriate
结局指标
主要结局
Rate of clinical complete response after radiotherapy
时间窗: 6-month after radiotherapy
complete resolution of disease in imaging or biopsy after low-dose radiotherapy
次要结局
- Overall response rate after radiotherapy(6-month after radiotherapy)
- Quality of Life change, QoL(1/3/6/12/24 months after radiotherapy)
- Progression-free survival rate at year 2 after enrollment, 2y-PFS(2-year)
- Rate of acute toxicity (any and above grade 3)(From enrollment to 3 months after treatment)
- Local control rate at year 2 after enrollment, 2y-LCR(2-year)
- Rate of late toxicity (any and above grade 3)(After 3 months of enrollment)
研究者
Shunan Qi
Associated Prof. in the radiation oncology department
Chinese Academy of Medical Sciences
研究点 (1)
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