Study to optimise the treatment for high risk neuroblastoma patients

Phase 1

• Conditions: High Risk Neuroblastoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-001489-17-HU
• Lead Sponsor: St. Anna Kinderkrebsforschung e.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-04
• Last Update Posted: 14 November 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2700

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.
•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: 2700
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified