Study to optimise the treatment for high risk neuroblastoma patients

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 3590

Inclusion Criteria

- 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: 3590
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1115
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any negative answer concerning the inclusion criteria of the study will render the patient ineligible for the corresponding therapy phase.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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