EUCTR2006-001489-17-SI进行中（未招募）1 期
High risk neuroblastoma study 1.5 of SIOP-Europe (SIOPEN) - HR-NBL-1.5
niversity medical center Ljubljana0 个研究点目标入组 2,230 人开始时间: 2013年7月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,230
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
- •- Established diagnosis of neuroblastoma according to the International Neuroblastoma Staging System (INSS)
- •- Age below 21 years
- •- High risk neuroblastoma, defined as either:
- •?a) INSS stages 2, 3, 4 and 4s with MYCN amplification, or
- •b) INSS stage 4 without MYCN amplification aged = 12 months - Patients who have received no previous chemotherapy except for 1
- •cycle of etoposide and carboplatin (Vp/Carbo). In this situation patients
- •will receive Rapid COJEC induction and the first COJEC cycle may be
- •replaced by the first cycle of Vp/Carbo.
- •- Written informed consent, including agreement of parents or legal
- •guardian for minors, to enter a randomised study if the criteria for
- •randomisation are met.
- •- Tumour cell material available for determination of biological
- •prognostic factors.
- •- Registration of all eligibility criteria with the data centre within
- •weeks from diagnosis.
- •- Provisional follow up of 5 years.
- •- National and local ethical committee approval.
- •The date of eligibility is defined as the date at which all criteria for entry
- •into the study have been checked by the co-ordinating centre along with
- •the referring physician. The date of diagnosis will be the starting point
- •for subsequent follow up.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2200
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any negative answer concerning the inclusion criteria of the study, R2
- •and R3 will render the patient ineligible for the corresponding therapy
研究者
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