Last updated on June 2018

High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Neuroblastoma
  • Age: Between 1 - 21 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Established diagnosis of neuroblastoma according to the International Neuroblastoma Staging System (INSS).
  • Age below 21 years.
  • High risk neuroblastoma defined as either:
    1. INSS stage 2, 3, 4, and 4s with MYCN amplification, or
    2. 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.
  • National and local ethical committee approval.

Exclusion Criteria:

Any negative answer concerning the inclusion criteria of the study

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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