Study to optimise the treatment for high risk neuroblastoma patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2230

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
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

Exclusion Criteria

Any negative answer concerning the inclusion criteria of the study, R2
and R3 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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