High Risk Neuroblastoma Study 1.5 of SIOP-Europe (SIOPEN) - HR-NBL-1.5

St. Anna Kinderkrebsforschung e.V.0 个研究点目标入组 2,230 人开始时间: 2012年6月15日最近更新: 2015年8月4日

适应症

试验速览

暂无简介。

•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.
•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

•Any negative answer concerning the inclusion criteria of the study, R2 and R3 will render the patient ineligible for the corresponding therapy phase.

发起方

St. Anna Kinderkrebsforschung e.V.