NCT00496743终止不适用
A Prospective, Open-Label Study on Low-Dose Total Skin Electron Beam Therapy in Mycosis Fungoides
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 主要终点
- Response rates
研究概览
简要总结
The purpise of this study was to determine the effect of low-dose (4 Gy) total skin electron beam therapy as a second-line treatment of stage IB-II mycosis fungoides.
详细描述
Current treatment modalities are usually not curative and having treatment options suitable for the long-term control therefore essential. Electron beam therapy is generally applied to the skin in total doses of 30-36 Gy over a 8-10 week period.Due to the potential risk of toxicity including bone marrow supression, no more than 2-3 courses in a life time are generally recommended. In the current study we explored the possibility of using lower radiation doses for total skin electron beam therapy for long-term disease control.
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
- •histologically confirmed mycosis fungoides stage I-II with failure to obtain full remission after standard PUVA treatment or relapse within 4 months of PUVA treatment
排除标准
- •under 18 years, pregnancy, other somatic diseases with a life expentancy under 1/2 years, psycological disorder preventing the patient to understand the information and cooperate in the treatment
结局指标
主要结局
Response rates
Duration of responses
次要结局
未报告次要终点
研究者
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暂停
不适用
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