High Risk Neuroblastoma Study 1.7 of SIOP-Europe (SIOPEN)R4 randomization for the use of the chimeric anti-GD2 antibody ch14.18 - HR-NBL-1.7/SIOPE

ST. ANNA KINDERKREBSFORSCHUNG e.V.0 个研究点目标入组 2,700 人开始时间: 2016年6月30日最近更新: 2016年9月12日

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 stage 2, 3, 4, and 4s with MYCN amplification, or
•b) INSS stage 4 without MYCN amplification aged > 12 months at diagnosis
•Patients who have received no previous chemotherapy except for one cycle of etoposide and carboplatin (VP16 / Carbo). In this situation patients will receive Rapid COJEC induction and the first Rapid COJEC cycle may be replaced by the first cycle VP16/Carbo (etoposide / carboplatin).
•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.
•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.
•Registration of all eligibility criteria with the data centre within 6 weeks from diagnosis.
•Provisional follow up of 5 years.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 2700
•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

•Any negative answer concerning the inclusion criteria of the study, R3 or R4 will render the patient ineligible for the corresponding therapy phase.

发起方

ST. ANNA KINDERKREBSFORSCHUNG e.V.