EUCTR2006-001271-38-IE进行中（未招募）不适用
Intensified pre-operative chemotherapy and radical surgery for HIGH RISK HEPATOBLASTOMASIOPEL 4 - SIOPEL 4
Our Lady's Hospital for Sick Children0 个研究点目标入组 57 人开始时间: 2006年5月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 57
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •?Histologically confirmed hepatoblastoma
- •?Risk category: high-risk (as defined above)
- •?Written informed consent and national/local ethical committee approval
- •?Ability to comply with requirements for submission of materials for central review
- •?Age less than 18 years
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •All patients who do not fulfil the eligibility criteria of the protocol are excluded from the trial Additional exclusion criteria are:
- •?Diagnosis not confirmed by histology
- •?Age greater thsn or equal to 18 years
- •?Any previous chemotherapy or any previous treatment for hepatoblastoma
- •?Interval between date of diagnostic biopsy and start of chemotherapy > 15 days
- •?Abnormal renal function at diagnosis defined as GFR < 75-50% of the lower limit of normal for age which over 2 years of age is < 60 ml/min/1.73 mP2 P
- •?Patient unable to follow the protocol for any reason.
- •?Patients referred for recurrent disease
- •?No written informed consent or no ethical committee approval
研究者
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