EUCTR2006-001489-17-IE进行中（未招募）1 期
High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN) - HR-NBL-1.8
St. Anna Kinderkrebsforschung e.V.0 个研究点目标入组 3,300 人开始时间: 2011年9月1日最近更新:
适应症
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
- 3,300
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 6 weeks from diagnosis.
- •- Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.
- •- Provisional follow up of 5 years.
- •- National and local ethical committee approval.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 3300
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •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 and R4 will render the patient ineligible for the corresponding therapy phase.
研究者
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