Etude : RSMA2010 / RSMA2010



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : RSMA2010

Nom : RSMA2010

Traitement : Adjuvant / Radiothérapie

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 01/06/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude prospective, nationale, multicentrique de phase II évaluant l’intérêt d’une radiothérapie avec désescalade de dose associée à une chimiothérapie par Carboplatine et Etoposide dans le traitement des médulloblastomes de l’adulte à risque standard

Spécialité : Oeil, cerveau et autres parties du système nerveux central
Localisation : C71 - Tumeur maligne de l'encéphale
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : We propose a phase II study to estimate the interest of a decrease of radiation doses compensated by a chemotherapy according to the following schedule
1. carboplatine + etoposide based chemotherapy every 28 days x 2
2. followed by, less than 80 days after the surgery, radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed.

The majority of French centres concerned with the neuro-oncology are involved in this trial.
About 25 new cases by year are waited. A centralized analysis of pathological slides and of the pre and post surgery Magnetic Resonance Imaging is foreseen.

The main objective is to estimate the survival without disease at 1 year

Secondary objectives associate the evaluations of the rate of complete response at the end of procedure, the overall survival, the survival without disease, the survival without events, the neurocognitiv toxicity, the endocrine toxicity, the hearing toxicity and the time until definitive deterioration of the quality of life Associated studies

Two associated studies are besides foreseen (parallel search for co-financing):
1. A biologic study is planed with the aim to confirm, by morphological, genomic and transcriptomic studies, the interest, for the adult population, of the prognostic markers used in paediatric population
2. A radiological study is planed with the aim to estimate the interest :
- of a multimodal follow-up (spectroscopy and perfusion imaging) for the premature detection of recurrences
- of the study of functional connectivity in correlation with the neuropsychological follow-up for the analysis of the aetiology and premature markers of neurotoxicity.

Phase : II

Stade : NA

1
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Pathologic diagnosis of medulloblastoma expect large cells type
- Patients between 18 and 70 years
- Résidual tumor les than 1.5 square centimeter (greater diameter)
- No sus tentorial or spinal location
- Absence of tumoral cells in the cerebrospinal fluid taken before, during or 14 days after surgery
- Absence of MYC amplification
- AID, B and C hepatitis positive serologies
- Negative βHCG dosage and effective contraception for potentially pregnant women
- Writed consent obtain

Critères de non-inclusion : - Age < 18 or > 70 years
- Previous diagnosis of medulloblastoma
- Previous treatment with chemotherapy
- Previous cranial or spinal radiation therapy
- Carboplatinum or etoposide contraindication
- Previous cancer in the five years before the inclusion except basocellular carcinoma of the skin and in situ cancer of the uterine cervix
- Severe renal renal insufficiency with a creatinine clearance < 60 ml/min
- Liver insufficiency with a contraindication of carboplatinum or etoposide based chemotherapy or elevated transaminases > 3N.
- Insufficient haematopoetic reserve (thrombocytes < 100 000/mm3 ou neutrophil polynuclear < 1500/mm3)
- Previous organ transplantation or immunosuppression
- Pregnant women or women without contraception
- Incapacity of respecting the recommanded follow up
- Participation in another therapeutic clinical trial
- Patient under custody
- Not social security regime membership
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
Promoteur :
CHU de Nancy
Type de sponsor : Institutionnel
29, avenue du Maréchal de Lattre de Tassigny - CO 60034
54000 NANCY

Coordonnateur :
Professeru Luc TAILLANDIER
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Docteur Emilie LE RHUN

TEC / ARC / IDE :
Camille GOMBERT
camille.gombert@
chru-lille.fr
03.20.44.59.62 poste 30444

Ouverture de l'essai : OUVERT

MAJ : 14/02/2019