A Phase II Trial of Low-Dose Radiotherapy for the Palliation of Patients With Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
Patients with Diffuse Large B-cell Lymphoma with indication for palliative radiotherapy are treated with low-dose radiation (2 x 2 Gy) to the symptomatic sites only. The primary endpoint of the study is the response rate and Quality of Life of the patients (QoL).
详细描述
Response is planned at 21-day after completion of the treatment. Response assessment is based on the standard definitions of the World Health Organization using complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) as response assessment criteria. The efficacy of the treatment consisted of a reduction greater than 50% of the maximum diameter of the radiated mass (PR + CR). QoL is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 3.0 version questionnaire. The QLQ-C30 questionnaire is self administered to the patients at baseline and at 21 days after treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven diagnosis of DLBCL with indication for palliative radiotherapy
排除标准
- 未提供
结局指标
主要结局
Response rate
时间窗: Clinical response up to 21 days after treatment
Clinical response is defined as reduction \> 50% of maximum diameter of the radiated lesion
次要结局
- Quality of life according to the EORTC QLQ-C30 questionnaire(The QLQ-C30 questionnaire is administered at baseline and at 21 days after treatment)