An International Clinical Program for the Diagnosis and Treatment of Children With Ependymoma

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

536

Participants

Timeline

Start Date

June 2, 2015

Primary Completion Date

June 30, 2028

Study Completion Date

August 31, 2031

Conditions
Childhood Ependymoma
Interventions
DRUG

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.

DRUG

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.

DRUG

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."

RADIATION

Conformal radiotherapy

Conformal radiotherapy: 59.4Gy (children \<18 months or with risk factors: 54Gy). Daily fraction 1.8 Gy, 5 fractions / week.

DRUG

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

DRUG

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.

RADIATION

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"

Trial Locations (40)

1000

NOT_YET_RECRUITING

University Medical Center Ljubljana, Ljubljana

4000

RECRUITING

CHR de la CITADELLE, Liège

5021

RECRUITING

Department of Paediatric, Haukeland University Hospital, Bergen

8032

RECRUITING

University Children's Hospital, Zurich

8036

RECRUITING

Medical University of Graz-Department of Pediatrics and Adolescent Medicine, Graz

8200

RECRUITING

Aarhus University Hospital, Aarhus

13385

RECRUITING

AP-HM - Hôpital d'Enfants de La Timone, Marseille

20133

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20246

RECRUITING

University Medical Center Hamburg-Eppendorf, Hamburg

21079

RECRUITING

CHU Dijon - Hôpital des Enfants, Dijon

22185

NOT_YET_RECRUITING

Skåne University Hospital, Lund

25030

RECRUITING

CHRU BESANCON - Hôpital Jean Minjoz, Besançon

29609

RECRUITING

CHRU BREST - Hôpital Morvan, Brest

31059

RECRUITING

CHU de TOULOUSE - Hôpital des Enfants, Toulouse

33000

RECRUITING

CHU de Bordeaux-Hôpital des enfants Pellegrin, Bordeaux

34295

RECRUITING

CHRU MONTPELLIER - Hôpital Arnaud de Villeneuve, Montpellier

35203

RECRUITING

CHU de RENNES - Hôpital Sud, Rennes

37044

RECRUITING

CHRU Tours - Hôpital Clocheville, Tours

38700

RECRUITING

CHU GRENOBLE - Hôpital Couple-Enfant, La Tronche

41071

RECRUITING

Hospitales Universitarios Virgen Macarena y Virgen del Rocío Avda, Seville

42055

RECRUITING

CHRU Saint-Etienne, Saint-Étienne-de-Montluc

49100

RECRUITING

Chu Angers, Angers

51092

RECRUITING

CHU REIMS - American Memorial Hospital, Reims

54511

RECRUITING

CHU NANCY - Brabois Hôpital d'Enfants, Vandœuvre-lès-Nancy

59000

RECRUITING

Centre OSCAR LAMBRET, Lille

61300

RECRUITING

University Hospital Brno, Brno

63003

RECRUITING

CHU Clermont- Ferrand - Hôpital Estaing, Clermont-Ferrand

67098

RECRUITING

CHRU STRASBOURG - Hôpital de Hautepierre, Strasbourg

69473

RECRUITING

Centre LEON BERARD, Lyon

75005

RECRUITING

Fondation Institut Curie, Paris

76031

RECRUITING

CHU Rouen - Hôpital Charles Nicolle, Rouen

80054

RECRUITING

CHU AMIENS-PICARDIE - Hôpital Nord, Amiens

86021

RECRUITING

CHU POITIERS - Hôpital de la Milétrie, Poitiers

94805

RECRUITING

Institut Gustave Roussy, Villejuif

97400

RECRUITING

CHU La Réunion, Saint-Denis

Unknown

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

06202

RECRUITING

CHU Nice - Hôpital de l'Archet 2, Nice

All Listed Sponsors
lead

Centre Leon Berard

OTHER