Etude : LINES / IC2011-07



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : LINES

Nom : IC2011-07

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 16/05/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : European Low and Intermediate Risk Neuroblastoma Protocol

Spécialité : Oeil, cerveau et autres parties du système nerveux central
Localisation : C69 - Tumeur maligne de l'oeil et de ses annexes

Spécialité : Voies urinaires
Localisation : C68 - Tumeur maligne des organes urinaires, autres et non précisés
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The European study, LINES 2009 (Low and Intermediate Risk Neuroblastoma European Study), groups together in a single protocol the treatment of all patients with "non high risk" neuroblastoma (NB), with stratification into two groups: low risk and intermediate risk. These two separate cohorts are included in one single protocol to enable patient data from these two groups to be entered into a common database, as the current prognostic classifications determining treatment may evolve further with subsequent more detailed molecular analysis of the tumours.

1. LOW RISK STUDY

The Low Risk Study is proposed in order to:
- minimise the amount of treatment (chemotherapy and surgery) for all appropriate low risk patients, who in previous studies have been shown to have an excellent long-term outcome (as in the SIOPEN 99.1-2 infant neuroblastoma studies where the overall survival was greater than 97%(H. Rubie, JCO).
- improve the EFS and maintain the OS (overall survival) in L2 and Ms patients with a SCA(Segmental Cromosomal Aberration) genomic profile tumour (presence of any segmental chromosomal change (SCA)) by electively treating these patients with chemotherapy despite the absence of symptoms.

2. INTERMEDIATE RISK STUDY

The Intermediate Risk Study is proposed in order to:
- reduce the amount of chemotherapy for differentiating histology INRG (International Neuroblastoma Risk Group) stage L2 NB and ganglioneuroblastoma nodular patients who in previous SIOPEN study have been shown to have an excellent long-term outcome;
- increase the amount of treatment (radiotherapy and 13-cis-RA (13-cis-Retinoic Acid) for poorly differentiated or undifferentiated histology INRG stage L2 NB or ganglioneuroblastoma nodular patients in order to improve the EFS registered in the previous SIOPEN study;
- improve the EFS (Event Free Survival) of MYCN (V-Myc myelocytomatosis viral related oncogene, NB derived ,avian )amplified INSS (International NB Staging System) stage 1 NB patients with the introduction of adjuvant treatment;
- maintain the very good results obtained in previous SIOPEN study for INRG stage M infants with a moderate treatment.

NEONATAL SUPRARENAL MASSES
The incidence of suprarenal tumours/masses has increased in the last decade due to the expanded use of prenatal ultrasonography in routine obstetric care and in the neonatal and early infancy care. The differential diagnosis of these masses ranges from benign (adrenal haemorrhage) to malignant processes (neuroblastoma, adrenal carcinoma). Knowledge on perinatal suprarenal masses, although based on a relatively large literature, is scattered amongst studies on very few cases with no methodical approach and often short follow up. Therefore, the optimal management of these masses has not been clearly defined. Neuroblastoma at this age is an intriguing entity with a very good prognosis in most cases. The SIOPEN Group, based on their results in the first multicenter European Trial for infants with neuroblastoma (INES) and the world-wide experience provided in the literature, is launching this European surveillance study (Multi-centre, non-blinded, one armed prospective trial) for these masses. Treatment: Observation

Phase : III

Stade : NA

1, 2, 3, 4, X
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : 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.

Critères de non-inclusion : 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.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT01728155
Promoteur :
Instituto de Investigacion Sanitaria La Fe
Type de sponsor : Institutionnel
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Docteur Anne-Sophie DEFACHELLES

TEC / ARC / IDE :
Unité Intégrée de Recherche Clinique
investigation@
o-lambret.fr
03.20.29.59.35

Ouverture de l'essai : OUVERT

MAJ : 16/05/2019