NCT00180908已完成3 期
SFOP-OS94: Multicentric Randomised Phase III Trial Comparing Efficacy of Preoperative High-Dose Methotrexate Plus Doxorubicin to Efficacy of High-Dose Methotrexate Plus Etoposide and Ifosfamide, in Children and Adolescents Osteosarcoma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- Good histological response (5% or less viable cells) after preoperative chemotherapy
研究概览
简要总结
The purpose of this study is to compare two preoperative chemotherapy regimens based on high-dose methotrexate courses given alternately either with doxorubicin or with etoposide-ifosfamide.
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
- — 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non metastatic limb osteosarcoma,
- •age less than 20 years,
- •biopsy proven high-grade osteosarcoma,
- •no previous treatment,
- •no contraindication to chemotherapy
- •no previous malignancy,
- •Written informed consent.
排除标准
- •juxta-cortical sarcoma and microcellular anaplastic sarcoma,
- •previous anticancer treatment
- •contraindication to chemotherapy
- •previous malignancy,
结局指标
主要结局
Good histological response (5% or less viable cells) after preoperative chemotherapy
次要结局
- Event-free survival,
- Overall survival,
- Toxicity.
研究者
研究点 (2)
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