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Clinical Trials/EUCTR2006-001489-17-SI
EUCTR2006-001489-17-SIActive, not recruitingPhase 1

High risk neuroblastoma study 1.5 of SIOP-Europe (SIOPEN) - HR-NBL-1.5

niversity medical center Ljubljana0 sites2,230 target enrollmentStarted: July 12, 2013Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
2,230
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

Investigators

Sponsor
niversity medical center Ljubljana

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