NCT00536458已完成3 期
Phase III Study of Treatment of Localized Lymphomas: Radiotherapy Versus Radio-Chemotherapie
French Innovative Leukemia Organisation1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 1999年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- failure free survival at 5 years
研究概览
简要总结
To compare localiezd radiotherapy to localized radiotherapy followed by 6 cycles of chemotherapy in the treatment of localiezd low grade lymphoma
详细描述
The standard treatment ol localized low grade lymphomas is Radiotherapy alone can offer long term remissions to some patients .
No study have clearly demonstrated the interest of chemotherapy. The purpose of the study is to determine wether prednisone administrated after first line local radiotherapy (30 GY) can pre in the treatment of localized low grade lymphomas of adult 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low grade lymphoma defined according to the Ann Arbor classification
- •localized
排除标准
- •Subjects unable to signed informed consent
- •Pregnancy
研究组 & 干预措施
radiotherapy
Experimental
minichep + radiotherapy
干预措施: radiotherapy (Procedure)
B
Active Comparator
MINI CHEP
干预措施: MINI CHEP (Drug)
结局指标
主要结局
failure free survival at 5 years
时间窗: 5 years
次要结局
- overall survival at 5 years(5 years)
- response rates at the end of the treatment(6 months)
- prognstic value of molecular analyses in blood and marrow(6 months)
研究者
研究点 (1)
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