Study for the low and intermediate risk of Neuroblastoma

Phase 1

• Conditions: INTERMEDIATE AND LOW RISK NEUROBLASTOMA; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-021396-81-GR
• Lead Sponsor: INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE DE VALENCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-21
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

Informed consent and follow-up warranted; group assignment completed within 6 weeks from diagnosis; no prior chemotherapy or radiotherapy,
Biopsy proven neuroblastoma
Tumour genomic profile obtained in a NRL according to guidelines
MYCNnon-amplified.
INRG STAGE L2: age = 18 months
INRG STAGE MS: age = 12 months

Are the trial subjects under 18? yes
Number of subjects for this age range: 540
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

Diagnosis of ganglioneuroma or ganglioneuroblastoma intermixed.
INRG STAGE L2:
any metastatic site
MYCN amplification
age >18 months.
INRG STAGE Ms:
bone metastasis
pleura/lung and/or CNS metastasis
MYCN amplification,
age > 12 months.

Study & Design

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