536
Participants
Start Date
June 2, 2015
Primary Completion Date
June 30, 2028
Study Completion Date
August 31, 2031
16 weeks of VEC + CDDP
Days 1-36-71-106: Vincristine: 1.5 mg/m² (maximal dose 2 mg) i.v.; Days 1-3-36-38-71-73-106-108: Etoposide: 100 mg/m² infused over 60 minutes; Days 1-36-71-106: Cyclophosphamide: 3000 mg/m² in 3 divided infusions (1000 mg/m²/infusion) infused over 60 minutes; Days 22-57-92: Cisplatin: 80 mg/m² over 4 hours + Vincristine:1.5 mg/m² (maximal dose 2 mg) i.v.
VEC + HD-MTX
Days 1-22-43: Vincristine: 1.5 mg/m² (maximal dose 2 mg) i.v.; Days 1-3-22-24-43-45: Etoposide: 100 mg/m² infused over 60 minutes; Days 1-22-43: Cyclophosphamide: 3000 mg/m² in 3 divided infusions (1000 mg/m²/infusion) infused over 60 minutes; Days 15-36-57: Administer methotrexate at 8000 mg/m² as a 24 hour IV infusion on days 15-36-57. 10% of the dose should be given over the first hour and 90% over the remaining 23 hours. The infusion must finish at 24 hours even if it has not been completed.
Chemotherapy + Valproate
"Days 1-57-113-169-225-281-337: Vincristine and Carboplatin; Days 15-71-127-183-239-295-351: Vincristine and Methotrexate; Days 29-85-141-197-253-309-365: Vincristine and Cyclophosphamide; Days 43-44-99-100-154-155-211-212-267-268-323-324-379-380: Cisplatin 2-day continuous infusion.~Valproate: initial dose 30 mg/kg/day for two weeks in 2 divided doses (BID 15 mg/kg). Increasing weekly up to 40 - 50 - 60 mg/kg/day in 2 divided doses."
Conformal radiotherapy
Conformal radiotherapy: 59.4Gy (children \<18 months or with risk factors: 54Gy). Daily fraction 1.8 Gy, 5 fractions / week.
VEC
D1: Vincristine: 1.5 mg/m² (maximal dose 2 mg) i.v.; D1-D3: Etoposide: 100 mg/m² infused over 60 minutes; D1: Cyclophosphamide: 3000 mg/m² in 3 divided infusions (1000 mg/m²/infusion) infused over 60 minutes; D22: Vincristine: 1.5 mg/m² (maximal dose 2 mg) i.v.; D22-D24: Etoposide: 100 mg/m² infused over 60 minutes; D22: Cyclophosphamide: 3000 mg/m² in 3 divided infusions (1000 mg/m²/infusion) infused over 60 minutes; D43: Vincristine: 1.5 mg/m² (maximal dose 2 mg) i.v.; D43-D45: Etoposide: 100 mg/m² infused over 60 minutes; D43: Cyclophosphamide: 3000 mg/m² in 3 divided infusions (1000 mg/m²/infusion) infused over 60 minutes
Chemotherapy
Days 1-57-113-169-225-281-337: Vincristine and Carboplatin; Days 15-71-127-183-239-295-351: Vincristine and Methotrexate; Days 29-85-141-197-253-309-365: Vincristine and Cyclophosphamide; Days 43-44-99-100-154-155-211-212-267-268-323-324-379-380: Cisplatin 2-day continuous infusion.
conformal radiotherapy +/- boost
"Conformal radiotherapy: 59.4Gy (children \<18 months or with risk factors: 54Gy). Daily fraction 1.8 Gy, 5 fractions / week.~In case of persistent residue : Boost of radiation 8 Gy in 2 equivalent fractions"
NOT_YET_RECRUITING
University Medical Center Ljubljana, Ljubljana
RECRUITING
CHR de la CITADELLE, Liège
RECRUITING
Department of Paediatric, Haukeland University Hospital, Bergen
RECRUITING
University Children's Hospital, Zurich
RECRUITING
Medical University of Graz-Department of Pediatrics and Adolescent Medicine, Graz
RECRUITING
Aarhus University Hospital, Aarhus
RECRUITING
AP-HM - Hôpital d'Enfants de La Timone, Marseille
RECRUITING
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan
RECRUITING
University Medical Center Hamburg-Eppendorf, Hamburg
RECRUITING
CHU Dijon - Hôpital des Enfants, Dijon
NOT_YET_RECRUITING
Skåne University Hospital, Lund
RECRUITING
CHRU BESANCON - Hôpital Jean Minjoz, Besançon
RECRUITING
CHRU BREST - Hôpital Morvan, Brest
RECRUITING
CHU de TOULOUSE - Hôpital des Enfants, Toulouse
RECRUITING
CHU de Bordeaux-Hôpital des enfants Pellegrin, Bordeaux
RECRUITING
CHRU MONTPELLIER - Hôpital Arnaud de Villeneuve, Montpellier
RECRUITING
CHU de RENNES - Hôpital Sud, Rennes
RECRUITING
CHRU Tours - Hôpital Clocheville, Tours
RECRUITING
CHU GRENOBLE - Hôpital Couple-Enfant, La Tronche
RECRUITING
Hospitales Universitarios Virgen Macarena y Virgen del Rocío Avda, Seville
RECRUITING
CHRU Saint-Etienne, Saint-Étienne-de-Montluc
RECRUITING
Chu Angers, Angers
RECRUITING
CHU REIMS - American Memorial Hospital, Reims
RECRUITING
CHU NANCY - Brabois Hôpital d'Enfants, Vandœuvre-lès-Nancy
RECRUITING
Centre OSCAR LAMBRET, Lille
RECRUITING
University Hospital Brno, Brno
RECRUITING
CHU Clermont- Ferrand - Hôpital Estaing, Clermont-Ferrand
RECRUITING
CHRU STRASBOURG - Hôpital de Hautepierre, Strasbourg
RECRUITING
Centre LEON BERARD, Lyon
RECRUITING
Fondation Institut Curie, Paris
RECRUITING
CHU Rouen - Hôpital Charles Nicolle, Rouen
RECRUITING
CHU AMIENS-PICARDIE - Hôpital Nord, Amiens
RECRUITING
CHU POITIERS - Hôpital de la Milétrie, Poitiers
RECRUITING
Institut Gustave Roussy, Villejuif
RECRUITING
CHU La Réunion, Saint-Denis
RECRUITING
CHU Limoges, Limoges
RECRUITING
Our Lady's Children's Hospital, Dublin
RECRUITING
Princess Maxima Center for pediatric oncology, Utrecht
RECRUITING
Queen's Medical Centre, Nottingham
RECRUITING
CHU Nice - Hôpital de l'Archet 2, Nice
Centre Leon Berard
OTHER