INES

Phase 1

Conditions: euroblastoma of low or intermediate risk
MedDRA version: 14.1Level: 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-FR

Lead Sponsor: INSTITUTO DE INVESTIGACION SANITARIA LA FE DE VALENCIA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 685

Inclusion Criteria

They are based on the age, stage, biological characteristics and presence of life threatening symptoms. As there are 3 groups of treatment, the criteria are different in each of them, see the protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Maintain and improve patient survival to increase or decrease the burden of treatment according to clinical and biological parameters.;Secondary Objective: Low risk: to maintain the event free survival to 85 % in L2 and Ms patients. To maintain the event free survival to 70 % in Ms with SCA patients.<br>Intermediate risk: to improve overall survival to 3 years in stage L2 patients over the age of 18 months and INSS stage I amplified. <br>Neonatal suprarenal masses: to maintain an excellent survival without initial surgery<br>;Primary end point(s): Time of initiation of chemotherapy (carboplatine and VP) during the 1 year following the diagnosis.;Timepoint(s) of evaluation of this end point: 1 year EFS . 2 years EFS. 3 years EFS. Dependin of the subgroup of study.

Secondary Outcome Measures