NCT00863460进行中（未招募）2 期
Prospective , Multicentric, Randomized Phase II Study, Evaluating the Role of Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue After Conventional Chemotherapy for Primary Central Nervous System in Young Patients (< 60 y)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 23
- 主要终点
- 2-years progression-free survival in each arm
研究概览
简要总结
Purpose of the study :
To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically or cytologically proven diagnostic of Primary CNS lymphoma
- •All histological types of non-Hodgkin's lymphoma, except MALT
- •Age > 18 and < 60 ans.
- •Negative for HIV, HCV and HBV
- •Written informed consent -
排除标准
- •Age < 18 or > 60 ans
- •Isolated intra-ocular lymphoma
- •Previous history of indolent lymphoma
- •Previous chemotherapy or radiotherapy for PCNSL
- •Isolated CNS relapse of systemic NHL
- •Previous history of cancer in the last 5 years, except basocellular carcinoma and non invasive cervix cancer
- •Renal insufficiency or creatinin clearance < 60 ml/min
- •Liver enzymes > 3N.
- •Platelets < 100 000/mm3 or neutrophils < 1500/mm3)
- •Previous history of organ transplantation or other cause of severe immunodeficiency
- •Pregnancy or active sexual women with no contraception
- •Unable to follow the protocol for any reason
研究组 & 干预措施
A
Active Comparator
MTX-based chemotherapy followed by WBRT
干预措施: cranial radiotherapy (Radiation)
A
Active Comparator
MTX-based chemotherapy followed by WBRT
干预措施: MTX based chemotherapy (Drug)
B
Experimental
MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue
干预措施: intensive chemotherapy and hematopoietic stem cell rescue (Drug)
B
Experimental
MTX-based chemotherapy followed by intensive chemotherapy and hematopoietic stem cell rescue
干预措施: MTX based chemotherapy (Drug)
结局指标
主要结局
2-years progression-free survival in each arm
时间窗: 2 years after inclusion
次要结局
- Overall response rate at the end of the procedure(at the end of procedure at 1 and 2 years)
- Overall survival(2 years after inclusion)
- Event-free survival(2 years after inclusion)
- Neurotoxicity(each years during ten years)
研究者
研究点 (23)
Loading locations...
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