Actively Recruiting
High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-06-26
800
Participants Needed
142
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an international, open-label, randomized phase III trial to evaluate the effectiveness of chemotherapy and radiotherapy treatments for patients with high-risk neuroblastoma. The study includes three sequential randomizations to compare different induction chemotherapy regimens, consolidation high-dose chemotherapy (HDC) approaches, and radiotherapy strategies. The goal is to improve event-free survival (EFS) over three years among children and young adults diagnosed with this aggressive cancer. The first randomization compares two induction chemotherapy regimens: RAPID COJEC versus GPOH. The second randomization assesses single HDC with Busulfan-Melphalan (Bu-Mel) versus tandem HDC with Thiotepa followed by Bu-Mel. For patients with macroscopic residual disease after surgery and HDC, the third randomization compares standard radiotherapy (21.6 Gy) to the tumor bed versus the same radiotherapy plus an additional boost (14.4 Gy). Patients without residual disease receive standard radiotherapy to the tumor bed. Treatments include various chemotherapy drugs, immunotherapy with dinutuximab beta, and radiotherapy delivered according to the assigned groups. Participants will undergo multiple assessments including disease evaluation after induction chemotherapy and surgery, blood tests, and monitoring of organ function. Researchers will measure event-free survival at one year after each randomization sequence. Patients are followed through the different phases of induction, consolidation, and radiotherapy, with adherence to protocol visits and procedures required. Safety and treatment responses are closely monitored throughout the study, which continues until the end date in November 2032.
CONDITIONS
Brief Title
High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of high-risk neuroblastoma according to SIOPEN-modified INRG criteria
- Age up to 21 years at time of randomization
- No previous chemotherapy or up to 21 days after one cycle of Carboplatin-Etoposide
- Negative pregnancy test for females of childbearing potential
- Use of acceptable contraception during and for one year after study treatment
- Written informed consent from patient or legal guardian, with assent when appropriate
- Affiliation to a social security or equivalent system
- Ability and willingness to comply with study visits and procedures
- Specific inclusion criteria for each randomization phase as per protocol
You will not qualify if you...
- Failure to meet any inclusion criteria
- Patient under guardianship or deprived of liberty
- Participation in another clinical trial with investigational medicinal product during study treatment
- Chronic inflammatory bowel disease or bowel obstruction
- Pregnant or breastfeeding women
- Known allergy to study drugs or excipients
- Use of medications that may interact with study drugs, including herbal supplements like St John's Wort
- Specific exclusions for R-I randomization such as severe urinary tract obstruction, heart failure, neuropathy, hearing impairment, or contraindications to hyperhydration
- Abnormal liver or kidney function exceeding defined limits
- Dyspnea at rest or low oxygen saturation (for certain randomization phases)
- Uncontrolled illness or infection
- Allergy to peanut or soya
- Concurrent use of live vaccines including yellow fever vaccine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Several weeks (varies with regimen)
Participants receive one of two induction chemotherapy regimens (RAPID COJEC or GPOH) to treat high-risk neuroblastoma.
Multiple visits during induction chemotherapy cycles
Duration - Several weeks (varies by regimen)
Participants receive high dose chemotherapy with either single Bu-Mel or tandem Thiotepa followed by Bu-Mel to consolidate treatment effects.
Multiple visits for chemotherapy administration and monitoring
Duration - Approximately 3 to 4 weeks
Participants with residual tumor receive radiotherapy to the tumor bed, either standard dose or with an additional boost depending on residual disease.
Daily visits for radiotherapy sessions during treatment period
Trial Site Locations
Total: 142 locations
1
Sydney children Hospital
Sydney, Randwick, Australia, NSW, 2031
Actively Recruiting
2
Children's Cancer Centre, Monash Children's Hospital
Clayton, Australia, VIC 3168
Actively Recruiting
3
Oncology/Haematology Department, Perth Children's Hospital
Nedlands, Australia, WA, 6009
Suspended
4
Children's Cancer & Haematology Services, John Hunter Children's Hospital
New Lambton Heights, Australia, NSW, 2305
Actively Recruiting
5
Australian and New Zealand Children's Hematology/oncology Group
Sydney, Australia, NSW, 2031
Active, Not Recruiting
6
sydney children Hospital
Sydney, Australia, NSW, 2031
Actively Recruiting
7
Cancer Centre for Children, The Children's Hospital
Westmead, Australia, NSW, 2145,
Suspended
8
Medical University Graz
Graz, Austria
Actively Recruiting
9
Landeskrankenhaus-Universitätsklinikum Innsbruck
Innsbruck, Austria
Actively Recruiting
10
Kepler Universitatsklinikum Linz
Linz, Austria
Actively Recruiting
11
Universitastsklinikum Salzburg
Salzburg, Austria
Actively Recruiting
12
St Anna'S Children Hospital
Vienna, Austria, A-1090
Actively Recruiting
13
Hôpital Universitaire des Enfants Reine Fabiola (ULB)
Brussels, Belgium, 1020
Actively Recruiting
14
Cliniques Universitaires Saint-Luc (UCL)
Brussels, Belgium, 1200
Actively Recruiting
15
University Hospital Gent
Ghent, Belgium, 9000
Actively Recruiting
16
University Hospitals Leuven
Leuven, Belgium, 3000
Actively Recruiting
17
CHR Citadelle
Liège, Belgium, 4000
Actively Recruiting
18
University Hospital Motol
Prague, Prague, Czechia, 15006
Actively Recruiting
19
Klinika dětské onkologie FN Brno
Brno, Czechia, 662 63
Not Yet Recruiting
20
Aarhus University Hospital
Aarhus, Denmark, DK-8200
Actively Recruiting
21
Department of Paediatrics and Adolescent Medicine, Rigshospitalet
Copenhagen, Denmark, DK-2100
Actively Recruiting
22
The Hans Christian Andersen Children's Hospital, University of Southern Denmark
Odense, Denmark, DK-5000
Actively Recruiting
23
New Children's Hospital, Helsinki University Hospital, Helsinki and Uusimaa Hospital District
Helsinki, Finland, 00029
Not Yet Recruiting
24
Kuopio University Hospital
Kuopio, Finland
Not Yet Recruiting
25
Oulu University Hospital
Oulu, Finland
Not Yet Recruiting
26
Tampere University Hospital
Tampere, Finland
Not Yet Recruiting
27
Turku University Hospital
Turku, Finland
Not Yet Recruiting
28
Gustave Roussy
Villejuif, Val De Marne, France, 94800
Actively Recruiting
29
CHU d'AMIENS
Amiens, France, 80054
Actively Recruiting
30
CHU angers
Angers, France
Actively Recruiting
31
CHU-Pôle Médico-Chirurgical de l'Enfant et l'Adolescant
Besançon, France
Actively Recruiting
32
CHU Bordeaux
Bordeaux, France, 33600
Actively Recruiting
33
Groupe Hospitalier Pellegrin - Chu - Bordeaux
Bordeaux, France
Actively Recruiting
34
CHU Brest
Brest, France, 29609
Actively Recruiting
35
CHU Brest - Hôpital du Morvan
Brest, France
Actively Recruiting
36
Centre François Baclesse
Caen, France
Active, Not Recruiting
37
CHU de Caen
Caen, France
Actively Recruiting
38
CHU Estaing
Clermont-Ferrand, France
Actively Recruiting
39
Centre Georges-François Leclerc
Dijon, France
Active, Not Recruiting
40
Hopital d'enfants Marechal de lattre
Dijon, France
Actively Recruiting
41
Hôpital Couple-Enfant CHU de Grenoble
Grenoble, France
Actively Recruiting
42
Chu de La Reunion - St Denis
La Réunion, France
Actively Recruiting
43
centre Oscar lambert
Lille, France
Actively Recruiting
44
Hôpital de la Mère et de l'Enfant - CHU Limoges
Limoges, France
Actively Recruiting
45
Centre Léon Berard
Lyon, France
Actively Recruiting
46
hopital la Timone
Marseille, France
Actively Recruiting
47
CHRU Nancy-Hôpital Brabois Enfant
Nancy, France
Actively Recruiting
48
Institut de cancérologie de Loraine
Nancy, France
Active, Not Recruiting
49
Centre Antoine Lacassagne
Nice, France
Active, Not Recruiting
50
CHU Nice-Hôpital d'Archet
Nice, France
Actively Recruiting
51
Hôpital Armand Trousseau
Paris, France
Actively Recruiting
52
institut Curie
Paris, France
Actively Recruiting
53
CHU Poitiers
Poitiers, France
Actively Recruiting
54
Hôpital Américain -CHU Reims
Reims, France
Actively Recruiting
55
Centre Eugène Marquis
Rennes, France
Active, Not Recruiting
56
CHU Rennes
Rennes, France
Actively Recruiting
57
Hôpital des Enfants - CHU Rouen
Rouen, France
Actively Recruiting
58
CHU Saint Etienne
Saint-Etienne, France
Actively Recruiting
59
Institut de cancérologie de l'Ouest - Sité René Gauducheau
Saint-Herblain, France
Active, Not Recruiting
60
CHU Haute Pierre
Strasbourg, France
Actively Recruiting
61
Institut de Cancérologie Strasbourg
Strasbourg, France
Active, Not Recruiting
62
Hopital des enfants-CHU Toulouse
Toulouse, France
Actively Recruiting
63
IUCT Oncopole
Toulouse, France
Active, Not Recruiting
64
CHU Tours Hôpital Clocheville
Tours, France
Actively Recruiting
65
charite universitatsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
66
Uniklinik Köln, Klinik und Poliklinik für Kinder und Jugendmedizin
Cologne, Germany, 50937
Not Yet Recruiting
67
Children's General Hospital "I AGHIA SOFIA"
Athens, Greece, 11527
Actively Recruiting
68
Children's General Hospital "P. & A. KYRIAKOU"
Athens, Greece, 11527
Actively Recruiting
69
"MITERA" Private, General, Obstetrics - Gynaecology, Paediatric Clinic S.A.
Athens, Greece, 15123
Actively Recruiting
70
Children's General Hospital "AGHIA SOFIA"
Athens, Greece
Actively Recruiting
71
University General Hospital of Heraklion (UnGHH)
Heraklion, Greece, 71500
Actively Recruiting
72
University General Hospital of Thessaloniki "AHEPA"
Thessaloniki, Greece, 54621
Actively Recruiting
73
General Hospital of Thessaloniki "IPPOKRATIO"
Thessaloniki, Greece, 54642
Actively Recruiting
74
RAMBAM Medical Center
Haifa, Israel
Actively Recruiting
75
A.O.U Policlinico di Bari
Bari, Italy, 70124
Actively Recruiting
76
Spedali civili Ospedale Dei Bambini Oncoematologia pediatrica e TMO
Brescia, Italy, 3995041
Actively Recruiting
77
policlinico rodolico San marco
Catania, Italy, 95123
Actively Recruiting
78
Azienda ospedaliero universtaria Anna Meyer
Florence, Italy, 50139
Actively Recruiting
79
instituto Giannina Gaslini genova
Genova, Italy, 16147
Actively Recruiting
80
IRCCS "Istituto Giannina Gaslini"
Genova, Italy, 16147
Actively Recruiting
81
Azienda Policlinico di Modena
Modena, Italy, 41100
Actively Recruiting
82
Azienda ospedaliero universitaria di Parma
Parma, Italy, 43126
Actively Recruiting
83
Policlino San matteo di Pavia
Pavia, Italy, 27100
Actively Recruiting
84
U.O Pediatria, SS Oncoematologia pediatrica
Rimini, Italy, 47900
Actively Recruiting
85
IRCCS Burlo Garoflo oncoematologia
Trieste, Italy, 34137
Actively Recruiting
86
U.O.C oncoematologia pediatrica ospedale Donna Bambino
Verona, Italy, 37126
Actively Recruiting
87
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania, 08406
Not Yet Recruiting
88
National Cancer Institute
Vilnius, Lithuania, 08660
Not Yet Recruiting
89
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9700
Active, Not Recruiting
90
Princess Maxima center
Utrecht, Netherlands, 3584CS
Actively Recruiting
91
Haukeland University Hospital
Haukeland, Norway
Actively Recruiting
92
Oslo University Hospital
Oslo, Norway, 0424
Actively Recruiting
93
University Hospital Northern Norway, Tromsoe
Tromsø, Norway
Not Yet Recruiting
94
St Olavs Hospital,
Trondheim, Norway
Not Yet Recruiting
95
Children's University Hospital Banská Bystrica
Banská Bystrica, Slovakia, 974 09
Not Yet Recruiting
96
NÚDCH- National Institute of Children's Diseases,
Bratislava, Slovakia, 833 40
Not Yet Recruiting
97
Children's University Hospital Košice
Košice, Slovakia, 040 11
Not Yet Recruiting
98
University medical center Ljubljana, University Children's Hospital Ljubljana, Slovenia
Ljubljana, Slovenia, 1000
Actively Recruiting
99
Hospital Universitario Son Espases
Balea, Spain, 07010
Actively Recruiting
100
Hospital Universitario Vall D´Hebron
Barcelona, Spain, 08035
Actively Recruiting
101
Hospital Universitario Cruces
Cruces, Spain, 48903
Actively Recruiting
102
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Spain, 30120
Actively Recruiting
103
Hospital Universitario Infantil Niño Jesús
Madrid, Spain, 28009
Actively Recruiting
104
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
105
Hospital Regional Universitario de Málaga
Málaga, Spain, 29010
Actively Recruiting
106
Hospital Universitario Donostia
San Sebastián, Spain, 20014
Actively Recruiting
107
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Spain, 15706
Actively Recruiting
108
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
109
Hospital Universitario Politécnico de La FE
Valencia, Spain
Actively Recruiting
110
Sahlgrenska University Hospital
Gothenburg, Sweden
Not Yet Recruiting
111
Linköping University Hospital
Linköping, Sweden
Not Yet Recruiting
112
Skåne University Hospital
Lund, Sweden
Not Yet Recruiting
113
Karolinska University Hospital, Stockholm
Stockholm, Sweden
Not Yet Recruiting
114
Norrland University Hospital
Umeå, Sweden
Not Yet Recruiting
115
Uppsala University Hospital
Uppsala, Sweden
Not Yet Recruiting
116
Kantonsspital Aarau AG Klinik für Kinder und Jugendliche
Aarau, Switzerland, CH-5001
Actively Recruiting
117
Universitäts-Kinderspital beider Basel (UKBB)
Basel, Switzerland, CH-4031
Actively Recruiting
118
Ospedale San Giovanni Pediatria, Emato-oncologia pediatrica
Bellinzona, Switzerland, CH-6500
Actively Recruiting
119
Inselspital, Universitätsklinik für Kinderheilkunde
Bern, Switzerland, CH-3010
Actively Recruiting
120
HUG Hôpitaux Universitaires de Genève Unité d'Hémato-Oncologie Pédiatrique
Geneva, Switzerland, CH-1205
Actively Recruiting
121
CHUV - Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Actively Recruiting
122
Luzerner Kantonsspital, Kinderspital pädiatrische Hämatologie/Onkologie
Lucerne, Switzerland, CH-6000
Actively Recruiting
123
Ostschweizer Kinderspital Hämatologie/Onkologie Claudiusstrasse 6
Sankt Gallen, Switzerland, CH-9006
Actively Recruiting
124
Division of Pediatric Oncology Universitäts-Kinderspital Zürich
Zurich, Switzerland, CH-8032
Actively Recruiting
125
Royal Aberdeen Children's Hospital
Aberdeen, United Kingdom
Actively Recruiting
126
Royal Belfast Hospital for Sick Children
Belfast, United Kingdom
Not Yet Recruiting
127
Birmingham children's Hospital
Birmingham, United Kingdom, B46NH
Actively Recruiting
128
University Hospitals Birmingham Queen Elisabeth Hospital(UHB)
Birmingham, United Kingdom, B46NH
Active, Not Recruiting
129
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom, BS1 3NU
Actively Recruiting
130
Addenbrookes Hospital, Cambridge
Cambridge, United Kingdom
Actively Recruiting
131
Noah's Ark Children's Hospital for Wales - Cardiff
Cardiff, United Kingdom
Not Yet Recruiting
132
Royal Hospital for Sick Children - Edinburgh
Edinburgh, United Kingdom
Not Yet Recruiting
133
Royal Hospital for Children Glasgow
Glasgow, United Kingdom, G34
Actively Recruiting
134
Leeds General Infirmary
Leeds, United Kingdom
Actively Recruiting
135
Alder Hey Children's Hospital - Liverpool
Liverpool, United Kingdom
Actively Recruiting
136
Great Ormond Street Hospital - London
London, United Kingdom
Actively Recruiting
137
Royal Manchester Children's Hospital
Manchester, United Kingdom
Actively Recruiting
138
Royal Victoria Infirmary, Newcastle
Newcastle, United Kingdom
Actively Recruiting
139
Nottingham Children's Hospital
Nottingham, United Kingdom
Actively Recruiting
140
Sheffield Children's Hospital
Sheffield, United Kingdom, S102TH
Actively Recruiting
141
Southampton General Hospital
Southampton, United Kingdom
Actively Recruiting
142
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
C
Claudia Pasqualini, MD PhD
H
Habiba Attalah, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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