Study for the low and intermediate risk of Neuroblastoma

Phase 1

• Conditions: ow and intermediate risk neuroblastom; MedDRA version: 20.0Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-021396-81-DK
• 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: 2012-02-29
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 685

Inclusion Criteria

The inclusion criterias are based on age, stage, biological characteristics, and presence of severe symptoms. The criterias are different in each treatment arm (See Protocol)
Are the trial subjects under 18? yes
Number of subjects for this age range: 25
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.
For low risk neuroblastoma stage L2: Any metastatic site, MYCN amplification and age >18 months
For low risk neuroblastoma stage Ms: Bone, pleura/lung and/or CNS metastasis, MYCN amplification and age > 12 months
For intermediate risk neuroblastama stage L1 and INSS stage: MYCN non-amplified, INSS stages 2, 3 , 4, 4s
For intermediate risk neuroblastama stage L2: neuroblastama NOS, MYCN amplification and age = 18 months
For intermediate risk neuroblastama stage M: MYCN amplification and age > 12 months

Study & Design

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