High Risk Neuroblastoma Study

Phase 1

• Conditions: High Risk Neuroblastoma; MedDRA version: 19.0Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-001489-17-GR
• Lead Sponsor: ST. ANNA KINDERKREBSFORSCHUNG e.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-30
• Last Update Posted: 12 September 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 stage 2, 3, 4, and 4s with MYCN amplification, or
b) 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 2700
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
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, R3 or 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