NCT01758666Unknown不适用
A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- blood concentration of MTX
研究概览
简要总结
At present, the most effective drugs to osteosarcoma include ADM,DDP,,HD-MTX,IFO and so on.The effective rate of single drug was about 30%, and if the chemotherapy contains HD-MTX, the survival rate can reach about 60%, so the HD-MTX is the most important component in patients of osteosarcoma.
Studies have shown that, MTX efficacy and adverse reactions were associated with blood concentration level and duration, selecting the right time and dose to give CF is the critical point.
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
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proved by pathology in 60 cases of osteosarcoma patients
- •PS ≤ 2, survival period is more than 6 months
- •Normal function of liver and kidney
- •No chemotherapy contraindication, patients treat with high dose methotrexate
- •Get signed written informed consent form
- •Have a good compliance with take blood and follow-up
排除标准
- 未提供
研究组 & 干预措施
Methotrexate and Calcium folinate
Experimental
干预措施: Methotrexate,Calcium folinate (Drug)
结局指标
主要结局
blood concentration of MTX
时间窗: up to 3 years
次要结局
- other adverse reaction(up to 3 years)
研究者
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