High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)

PHASE3RecruitingINTERVENTIONAL
Enrollment

800

Participants

Timeline

Start Date

November 5, 2019

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2032

Conditions
High-Risk NeuroblastomaPatient With Insufficient Response Chemoimmunotherapy
Interventions
DRUG

Vincristine

1.5 mg/m2 (max dose 2 mg)

DRUG

Carboplatin

750 mg/m2

DRUG

Etoposide

175 mg/m2

DRUG

Vindesine

3 mg/m2/day (max dose 6 mg)

DRUG

Dacarbazine

200 mg/m2/day

DRUG

Ifosfamide

1500 mg/m2/day

DRUG

Doxorubicin

30 mg/m2/dose

DRUG

Busulfan

\< 9kg: 1.0 mg/kg/dose 9 kg to \< 16 kg : 1.2 mg/kg/dose 16 kg to 23 kg : 1.1 mg/kg/dose \>23 kg to 34 kg: 0.95 mg/kg/dose \>34 kg: 0.8 mg/kg/dose Infusion IV over 2 hours Administration every 6 hours for a total of 16 doses

DRUG

Melphalan

140 mg/m2/dose IV short infusion (15'), at least 24 h after the last busulfan dose

DRUG

Thiotepa

300 mg/m2/day over 2 hours

RADIATION

Radiotherapy

21.6 Gy 21.6 Gy + boost de 14.4 Gy

DRUG

Dinutuximab Beta

Patients \>12 kg are dosed based on the BSA: 10 mg/m\^2/day Patients ≤ 12 kg are dosed according to their body weight: 0.33 mg/kg/day

DRUG

Cisplatin

80 mg/m2/24h

DRUG

Temozolomide 100 MG

100 mg/m²/Day

DRUG

Irinotecan

50 mg/m²/jour de J0 à J4

DRUG

Cyclophosphamid

Cyclophosphamide has been demonstrated to have a cytostatic effect in many tumour types. The active metabolites of cyclophosphamide are alkylating agents which transfer alkyl groups to DNA during the process of cell division, thus preventing normal synthesis of DNA.

Trial Locations (142)

1000

RECRUITING

University medical center Ljubljana, University Children's Hospital Ljubljana, Slovenia, Ljubljana

1020

RECRUITING

Hôpital Universitaire des Enfants Reine Fabiola (ULB), Brussels

1200

RECRUITING

Cliniques Universitaires Saint-Luc (UCL), Brussels

3000

RECRUITING

University Hospitals Leuven, Leuven

4000

RECRUITING

CHR Citadelle, Liège

9000

RECRUITING

University Hospital Gent, Ghent

9700

ACTIVE_NOT_RECRUITING

Universitair Medisch Centrum Groningen, Groningen

11527

RECRUITING

"Children's General Hospital I AGHIA SOFIA", Athens

RECRUITING

"Children's General Hospital P. & A. KYRIAKOU", Athens

13353

RECRUITING

charite universitatsmedizin Berlin, Berlin

15006

RECRUITING

University Hospital Motol, Prague

15123

RECRUITING

"MITERA Private, General, Obstetrics - Gynaecology, Paediatric Clinic S.A.", Athens

15706

RECRUITING

Hospital Clínico Universitario de Santiago, Santiago de Compostela

16147

RECRUITING

instituto Giannina Gaslini genova, Genova

RECRUITING

"IRCCS Istituto Giannina Gaslini", Genova

20014

RECRUITING

Hospital Universitario Donostia, San Sebastián

27100

RECRUITING

Policlino San matteo di Pavia, Pavia

28009

RECRUITING

Hospital Universitario Infantil Niño Jesús, Madrid

28046

RECRUITING

Hospital Universitario La Paz, Madrid

29010

RECRUITING

Hospital Regional Universitario de Málaga, Málaga

29609

RECRUITING

CHU Brest, Brest

30120

RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar

33600

RECRUITING

CHU Bordeaux, Bordeaux

34137

RECRUITING

IRCCS Burlo Garoflo oncoematologia, Trieste

37126

RECRUITING

U.O.C oncoematologia pediatrica ospedale Donna Bambino, Verona

41013

RECRUITING

Hospital Universitario Virgen del Rocío, Seville

41100

RECRUITING

Azienda Policlinico di Modena, Modena

43126

RECRUITING

Azienda ospedaliero universitaria di Parma, Parma

47900

RECRUITING

U.O Pediatria, SS Oncoematologia pediatrica, Rimini

48903

RECRUITING

Hospital Universitario Cruces, Cruces

50139

RECRUITING

Azienda ospedaliero universtaria Anna Meyer, Florence

50937

NOT_YET_RECRUITING

Uniklinik Köln, Klinik und Poliklinik für Kinder und Jugendmedizin, Cologne

54621

RECRUITING

"University General Hospital of Thessaloniki AHEPA", Thessaloniki

54642

RECRUITING

"General Hospital of Thessaloniki IPPOKRATIO", Thessaloniki

70124

RECRUITING

A.O.U Policlinico di Bari, Bari

71500

RECRUITING

University General Hospital of Heraklion (UnGHH), Heraklion

80054

RECRUITING

CHU d'AMIENS, Amiens

94800

RECRUITING

Gustave Roussy, Villejuif

95123

RECRUITING

policlinico rodolico San marco, Catania

3995041

RECRUITING

Spedali civili Ospedale Dei Bambini Oncoematologia pediatrica e TMO, Brescia

NSW, 2031

RECRUITING

Sydney children Hospital, Sydney

ACTIVE_NOT_RECRUITING

Australian and New Zealand Children's Hematology/oncology Group, Sydney

RECRUITING

sydney children Hospital, Sydney

VIC 3168

RECRUITING

Children's Cancer Centre, Monash Children's Hospital, Clayton

WA, 6009

SUSPENDED

Oncology/Haematology Department, Perth Children's Hospital, Nedlands

NSW, 2305

RECRUITING

Children's Cancer & Haematology Services, John Hunter Children's Hospital, New Lambton Heights

NSW, 2145,

SUSPENDED

Cancer Centre for Children, The Children's Hospital, Westmead

Unknown

RECRUITING

Medical University Graz, Graz

RECRUITING

Landeskrankenhaus-Universitätsklinikum Innsbruck, Innsbruck

RECRUITING

Kepler Universitatsklinikum Linz, Linz

RECRUITING

Universitastsklinikum Salzburg, Salzburg

NOT_YET_RECRUITING

Kuopio University Hospital, Kuopio

NOT_YET_RECRUITING

Oulu University Hospital, Oulu

NOT_YET_RECRUITING

Tampere University Hospital, Tampere

NOT_YET_RECRUITING

Turku University Hospital, Turku

RECRUITING

CHU angers, Angers

RECRUITING

CHU-Pôle Médico-Chirurgical de l'Enfant et l'Adolescant, Besançon

RECRUITING

Groupe Hospitalier Pellegrin - Chu - Bordeaux, Bordeaux

RECRUITING

CHU Brest - Hôpital du Morvan, Brest

ACTIVE_NOT_RECRUITING

Centre François Baclesse, Caen

RECRUITING

CHU de Caen, Caen

RECRUITING

CHU Estaing, Clermont-Ferrand

ACTIVE_NOT_RECRUITING

Centre Georges-François Leclerc, Dijon

RECRUITING

Hopital d'enfants Marechal de lattre, Dijon

RECRUITING

Hôpital Couple-Enfant CHU de Grenoble, Grenoble

RECRUITING

Chu de La Reunion - St Denis, La Réunion

RECRUITING

centre Oscar lambert, Lille

RECRUITING

Hôpital de la Mère et de l'Enfant - CHU Limoges, Limoges

RECRUITING

Centre Léon Berard, Lyon

RECRUITING

hopital la Timone, Marseille

RECRUITING

CHRU Nancy-Hôpital Brabois Enfant, Nancy

ACTIVE_NOT_RECRUITING

Institut de cancérologie de Loraine, Nancy

ACTIVE_NOT_RECRUITING

Centre Antoine Lacassagne, Nice

RECRUITING

CHU Nice-Hôpital d'Archet, Nice

RECRUITING

Hôpital Armand Trousseau, Paris

RECRUITING

institut Curie, Paris

RECRUITING

CHU Poitiers, Poitiers

RECRUITING

Hôpital Américain -CHU Reims, Reims

ACTIVE_NOT_RECRUITING

Centre Eugène Marquis, Rennes

RECRUITING

CHU Rennes, Rennes

RECRUITING

Hôpital des Enfants - CHU Rouen, Rouen

RECRUITING

CHU Saint Etienne, Saint-Etienne

ACTIVE_NOT_RECRUITING

Institut de cancérologie de l'Ouest - Sité René Gauducheau, Saint-Herblain

RECRUITING

CHU Haute Pierre, Strasbourg

ACTIVE_NOT_RECRUITING

Institut de Cancérologie Strasbourg, Strasbourg

RECRUITING

Hopital des enfants-CHU Toulouse, Toulouse

ACTIVE_NOT_RECRUITING

IUCT Oncopole, Toulouse

RECRUITING

CHU Tours Hôpital Clocheville, Tours

RECRUITING

"Children's General Hospital AGHIA SOFIA", Athens

RECRUITING

RAMBAM Medical Center, Haifa

RECRUITING

Haukeland University Hospital, Haukeland

NOT_YET_RECRUITING

University Hospital Northern Norway, Tromsoe, Tromsø

NOT_YET_RECRUITING

St Olavs Hospital,, Trondheim

RECRUITING

Hospital Universitario Politécnico de La FE, Valencia

NOT_YET_RECRUITING

Sahlgrenska University Hospital, Gothenburg

NOT_YET_RECRUITING

Linköping University Hospital, Linköping

NOT_YET_RECRUITING

Skåne University Hospital, Lund

NOT_YET_RECRUITING

Karolinska University Hospital, Stockholm, Stockholm

NOT_YET_RECRUITING

Norrland University Hospital, Umeå

NOT_YET_RECRUITING

Uppsala University Hospital, Uppsala

RECRUITING

Royal Aberdeen Children's Hospital, Aberdeen

NOT_YET_RECRUITING

Royal Belfast Hospital for Sick Children, Belfast

RECRUITING

Addenbrookes Hospital, Cambridge, Cambridge

NOT_YET_RECRUITING

Noah's Ark Children's Hospital for Wales - Cardiff, Cardiff

NOT_YET_RECRUITING

Royal Hospital for Sick Children - Edinburgh, Edinburgh

RECRUITING

Leeds General Infirmary, Leeds

RECRUITING

Alder Hey Children's Hospital - Liverpool, Liverpool

RECRUITING

Great Ormond Street Hospital - London, London

RECRUITING

Royal Manchester Children's Hospital, Manchester

RECRUITING

Royal Victoria Infirmary, Newcastle, Newcastle

RECRUITING

Nottingham Children's Hospital, Nottingham

RECRUITING

Southampton General Hospital, Southampton

A-1090

RECRUITING

St Anna'S Children Hospital, Vienna

662 63

NOT_YET_RECRUITING

Klinika dětské onkologie FN Brno, Brno

DK-8200

RECRUITING

Aarhus University Hospital, Aarhus

DK-2100

RECRUITING

Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen

DK-5000

RECRUITING

The Hans Christian Andersen Children's Hospital, University of Southern Denmark, Odense

00029

NOT_YET_RECRUITING

New Children's Hospital, Helsinki University Hospital, Helsinki and Uusimaa Hospital District, Helsinki

08406

NOT_YET_RECRUITING

Vilnius University Hospital Santaros Klinikos, Vilnius

08660

NOT_YET_RECRUITING

National Cancer Institute, Vilnius

3584CS

RECRUITING

Princess Maxima center, Utrecht

0424

RECRUITING

Oslo University Hospital, Oslo

974 09

NOT_YET_RECRUITING

Children's University Hospital Banská Bystrica, Banská Bystrica

833 40

NOT_YET_RECRUITING

NÚDCH- National Institute of Children's Diseases,, Bratislava

040 11

NOT_YET_RECRUITING

Children's University Hospital Košice, Košice

07010

RECRUITING

Hospital Universitario Son Espases, Balea

08035

RECRUITING

Hospital Universitario Vall D´Hebron, Barcelona

CH-5001

RECRUITING

Kantonsspital Aarau AG Klinik für Kinder und Jugendliche, Aarau

CH-4031

RECRUITING

Universitäts-Kinderspital beider Basel (UKBB), Basel

CH-6500

RECRUITING

Ospedale San Giovanni Pediatria, Emato-oncologia pediatrica, Bellinzona

CH-3010

RECRUITING

Inselspital, Universitätsklinik für Kinderheilkunde, Bern

CH-1205

RECRUITING

HUG Hôpitaux Universitaires de Genève Unité d'Hémato-Oncologie Pédiatrique, Geneva

CH-1011

RECRUITING

CHUV - Centre Hospitalier Universitaire Vaudois, Lausanne

CH-6000

RECRUITING

Luzerner Kantonsspital, Kinderspital pädiatrische Hämatologie/Onkologie, Lucerne

CH-9006

RECRUITING

Ostschweizer Kinderspital Hämatologie/Onkologie Claudiusstrasse 6, Sankt Gallen

CH-8032

RECRUITING

Division of Pediatric Oncology Universitäts-Kinderspital Zürich, Zurich

B46NH

RECRUITING

Birmingham children's Hospital, Birmingham

ACTIVE_NOT_RECRUITING

University Hospitals Birmingham Queen Elisabeth Hospital(UHB), Birmingham

BS1 3NU

RECRUITING

University Hospitals Bristol and Weston NHS Foundation Trust, Bristol

G34

RECRUITING

Royal Hospital for Children Glasgow, Glasgow

S102TH

RECRUITING

Sheffield Children's Hospital, Sheffield

SM2 5PT

RECRUITING

Royal Marsden Hospital, Sutton

All Listed Sponsors
lead

Gustave Roussy, Cancer Campus, Grand Paris

OTHER