NCT00162695终止3 期
Rhabdomyosarcoma and Malignant Soft Tissue Tumours of Childhood
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- To explore survival advantage for an intensified chemotherapy strategy in a randomised trial
研究概览
简要总结
Objective of the study objectives was to explore survival advantage for an intensified chemotherapy strategy in a randomised trial.
IVA (ifosfamide, vincristine, actinomycin D) or a 6 drug combination (IVA + carboplatin, epirubicin, etoposide) both delivered over 27 weeks. Cumulative dose / m2 = ifosfamide 54g (both arms), epirubicin 450 mg, etoposide 1350 mg (6 drug). Delivery of radiotherapy was determined according to site and / or response to chemotherapy ± surgery.
The study was powered to detect 10% difference in 3 year OS.
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
- 6 Months 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 6 months and < 18 years
- •no distant metastases
- •diagnosis within previous 8 weeks without prior treatment except surgery
- •pathology available for central review
- •written consent according to institutional requirement
排除标准
- •stage III (node positive)
- •stage I or II non alveolar orbital tumours
- •patients with parameningeal disease aged < 3 years
结局指标
主要结局
To explore survival advantage for an intensified chemotherapy strategy in a randomised trial
次要结局
未报告次要终点
研究者
研究点 (2)
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