Back to resultsEuropean Low and Intermediate Risk Neuroblastoma Protocol
Primary Purpose
LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES focused on measuring NEUROBLASTOMA, LOW RISK, INTERMEDIATE RISK
Eligibility Criteria
LOW RISK STUDY
Inclusion criteria for the whole low risk group:
- informed consent and follow-up warranted; group assignment completed within 6 weeks from diagnosis; no prior chemotherapy or radiotherapy
- Biopsy proven neuroblastoma
- Tumour genomic profile obtained in a NRL according to guidelines
- MYCN non-amplified
Exclusion criteria for the whole low risk group:
* Diagnosis of ganglioneuroma or ganglioneuroblastoma intermixed INRG Stage L2
Inclusion criteria:
*age ≤ 18 months
Exclusion criteria:
- any metastatic site
- MYCN amplification
- age > 18 months INRG Stage Ms
Inclusion criteria:
* age ≤ 12 months
Exclusion criteria:
- bone, pleura/lung and/or CNS metastasis
- MYCN amplification
- age > 12 months
INTERMEDIATE RISK STUDY
Inclusion criteria for the whole intermediate risk group:
- informed consent and follow-up warranted; group assignment completed within 6 weeks from diagnosis; no prior chemotherapy or radiotherapy
- Tumour material available for biological studies according to guidelines
- Biopsy proven neuroblastoma confirmed in a National Reference Laboratory (NRL)
Exclusion criteria for the whole intermediate risk group:
* Diagnosis of ganglioneuroma or ganglioneuroblastoma intermixed
INRG Stage L1 and INSS stage 1:
Inclusion criteria:
* MYCN amplified
Exclusion criteria:
- MYCN non-amplified
- INSS stages 2, 3, 4, 4s
INRG Stage L2:
Inclusion criteria:
- Histology: differentiating, poorly differentiated, undifferentiated neuroblastoma or ganglioneuroblastoma nodular
- MYCN non-amplified
- age >18 months
Exclusion criteria:
- neuroblastoma NOS
- MYCN amplification.
- age ≤ 18 months
INRG Stage M:
Inclusion criteria:
- Any histology
- MYCN non-amplified
- age ≤ 12 months
Exclusion criteria:
- MYCN amplification
- age > 12 months
- NEONATAL SUPRARENAL MASSES
Inclusion criteria:
- Age less than or equal to 90 days when the suprarenal mass is discovered.
- Suprarenal mass detected by ultrasound and/or MRI. The suprarenal mass may be cystic and/or solid, but IT CANNOT REACH THE MIDLINE AND should MEASURE ≤ 5 CM AT THE LARGEST DIAMETER.
- No regional involvement: MRI scan does not show evidence of positive ipsi/contralateral lymph nodes or other spread outside the suprarenal gland.
- No metastatic involvement.
- Frozen plasma available.
- Informed consent.
- Availability to do the adequate follow-up
Exclusion criteria:
- Age older than 90 days.
- Suprarenal mass bigger than 5 cm.
- Regional involvement.
- Metastatic involvement.
- Inability to undertake mandatory diagnostic studies (biological markers, US, MRI, MIBG).
- Follow-up not guaranteed by parents/guardians.
Sites / Locations
- Monash Children's Hospital
- Perth Children's Hospital
- Sydney Children's Hospital
- PHO Med Uni Graz
- Department Kinder- und Jugendheilkunde
- Landes-Frauen- und Kinderklinik Linz
- St. Anna Kinderspital
- Univ Klinik für Kinder- und Jugendheilkunde
- Hôpital Universitaire d'Anvers (UZA- Universitair Ziekenhuis Antwerpen)
- Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
- UCL Clíniques Universitaires Saint - Luc
- Universitair Ziekenhuis Brussel
- Universitair Ziekenhuis Gent
- Universitair Ziekenhuis Leuven
- CHC- Clinique de l'Espérance à Liège
- CHR de la Citadelle
- Aarhus University Hospital
- National State Hospital (Department of Pediatrics)
- University Hospital of Odense (H.C. Andersen Children´s Hospital)
- Soroka Medical Center
- Rambam Health Care Campus
- Schneider Children's Medical Center
- Ichilov Hospital Sourasky Medical Center
- Ospedale Pediatrico G. Salesi di Ancona (Centro Regionale Oncoematologia Pediatrica)
- Azienda Ospedaliera - Universitaria Ospedale Policlinico Consorziale
- Azienda Ospedaliera Ospedali Riuniti di Bergamo
- Azienda Ospedaliero- Universitaria di Bologna- Policlinico S. Orsola - Malpighi
- Azienda Ospedaliera Spedali Civili di Brescia
- Ospedale Microcitemico
- Oncology Policlinico- Department of Hematology
- Azienda Ospedaliero-Universitaria di Ferrara- Oncoematologia Pediatrica
- Azienda Ospedaliero-Universitaria Ospedale Pediatrico Meyer
- Oncology Gaslini Children's Hospital of Genova- Department of Hematology
- Istituto Nazionale dei Tumori di Milano- Onco-ematologia Pediatrica
- Azienda Ospedaliero-Universitaria Policlinico di Modena- Onco-ematologia Pediatrica
- Azienda Ospedaliera Pediatrica Santobono Pausilipon
- Sec. Università degli studi di Napoli - Policlinico
- Azienda Ospedaliera-Universitaria di Padova- Clínica di Onco-ematologia Pediatrica
- Ospedale dei Bambini G. Di Cristina
- Azienda Ospedaliero - Universitaria di Parma- Oncoematologia Pediatrica
- Fondazione IRCCS - Policlinico San Matteo - Oncoematologia Pediadrica
- Azienda USL Di Pescara - U.O.C di Ematologia Clinica
- Ospedale Infermi di Rimini - U.O. Pediatria
- Ospedale Pediatrico Bambino Gesù- Oncoematologia pediatrica
- Ospedale Policlinico Universitario Agostino Gemelli
- Policlinico Umberto I
- Casa Sollievo della Sofferenza
- Azienda Ospedaliera Universitaria Senese - Clinica Pediatrica
- Azienda Sanitaria Ospedaliera O.I.R.M.- Sant' Anna
- Ospedale Cardinale G. Panico
- Ospedale Infantile Burlo Garofolo ( U.O. Emato-Oncologia Pediatrica - Università degli studi di Trieste)
- Policlinico G.B. Rossi- Oncoematologia Pediatrica
- Haukeland University Hospital
- Oslo University Hospital, Rikshospitalet. (National coordinator)
- University Hospital of Northern Norway
- St Olavs University Hospital
- Hospital de Sabadell
- Hospital Universitario Montepríncipe
- Hospital Universitario de Canarias
- Hospital General Universitario de Albacete
- Hospital General Universitario de Alicante
- Complejo Hospitalario Torrecárdenas
- Hospital Infanta Cristina
- Hospital de la Santa Creu i Sant Pau
- Hospital Materno Infantil Vall d'Hebron
- Hospital Universitario Cruces
- Hospital Universitario Reina Sofía
- Hospital Universitario Materno Infantil Virgen de las Nieves
- Hospital Materno Infantil de Jaén
- Hospital Universitario 12 de Octubre
- Hospital Universitario Infantil la Paz
- Hospital Universitario Infantil Niño Jesús
- Hospital Universitario Virgen de la Arrixaca
- Hospital Regional Universitario Carlos Haya - Hospital Materno Infantil
- Hospital Universitario Central de Asturias
- Hospital Virgen del Camino
- Hospital Universitario Donostia
- Hospital Universitario de Santiago
- Hospital Universitario Virgen del Rocío
- Hospital Universitario Virgen Macarena
- Instituto de Investigacion Sanitaria La Fe
- Hospital Clínic Universitari
- Hospital Universitario Miguel Servet
- Queen Silvia's Children's Hospital
- Linköping University Hospital
- Skåne University Hospital
- Karolinska University Hospital
- Norrlands University Hospital
- Uppsala Academic Children's Hospital
- Kantonsspital Aarau
- Universitäts-Kinderspital beider Basel
- Ospedale San Giovanni
- Inselspital Bern
- HUG Hôpitaux Universitaires Genève
- CHUV - Centre Hospitalier Universitaire Vaudois - Unité d'hémato-oncologie pédiatrique
- Luzerner Kantonsspital
- Ostschweizer Kinderspital
- Universitäts-Kinderspital Zürich
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm Type
No Intervention
Active Comparator
Experimental
Experimental
No Intervention
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Group1
Group 1: chemotherapy
Group 2
Group 3
Group 4
Group 5
Group 6
Group 7
Group 8
Group 9
Group 10
Arm Description
initial observation (chemotherapy is only given if there is subsequent progression)
chemotherapy and surgery
chemotherapy and surgery
chemotherapy and surgery
Observation
chemotherapy
chemotherapy and surgery
chemotherapy and surgery
chemotherapy, surgery, radiotherapy and 13 cis-retinoic acid
chemotherapy, surgery, radiotherapy and 13 cis-retinoic acid
chemotherapy, surgery,
Outcomes
Primary Outcome Measures
Primary aim for Low Risk Neuroblastoma
To demonstrate through a randomisation between observation and chemotherapy that you can safely reduce treatment in a subgroup of L2 low risk patients (those without life threatening symptoms (LTS) and without any segmental chromosomal changes (SCA), i.e. study group 1) by giving less treatment than has been given historically while maintaining an excellent OS of 100%.
Primary aim for Intermediate Risk Neuroblastoma
To improve the EFS to 70% with an OS of 90% of INRG stage L2 patients over the age of 18 months, with poorly differentiated or undifferentiated tumour histology (INPC criteria), by the addition of radiotherapy and 13-cis RA compared to historical conventional treatment (study group 8).
Primary Aim for Neonatal Suprarenal Masses
To maintain a 3-year event free survival over 80% with a non-operative therapeutic approach (serial monitoring, surgery if warranted) in infants with a localised suprarenal mass discovered ante or neonatally.
Secondary Outcome Measures
To maintain a 2 year EFS of at least 90% and an OS of at least 95% in L2 patients with LTS without SCA (study group 2)
To maintain the 2 year EFS of 85% and an OS of at least 98% in Ms patients without SCA (study groups 4 and 5)
To improve the 2 year EFS to at least 90% and maintain the OS of close to 100% in L2 patients with SCA (Study Group 3) and improve the 2 year EFS to over 70% in Ms patients with SCA (study group 6)
To evaluate adherence to the protocol recommendations regarding LTS
To reduce surgical morbidity by promoting strict adherence to Image Defined-Risk Factors (IDRFs) to determine surgical resectability
To define the long term follow-up and natural history of the Stage L2 non-resected masses that have remained IDRF positive at the end of treatment (study groups 1-3).
To confirm in a larger patient cohort the excellent OS of 95% in stage M neuroblastoma without MYCN amplification, less than 12 months of age, when treated with moderate therapy (study group 10).
Maintain the results of 3yr-EFS of 90% and 3yr-OS of 100% in stage L2 patients over the age of 18 months, with differentiating neuroblastoma or differentiating ganglioneuroblastoma nodular, despite a treatment reduction (group7)
To improve the 3 year EFS to at least 50% and the 3 year OS to 80% in INSS stage I patients with MYCN amplified neuroblastoma by the addition of adjuvant treatment (study group 9).
To evaluate the impact of the tumour genomic profile on patient outcome, in order to consider its role in the treatment stratification of these intermediate risk patients (all study groups).
To manage infants with suprarenal masses discovered ante or neonatally with a uniform approach in Europe in a multicentre setting.
To maintain an excellent overall survival with a non-operative therapeutic approach (serial monitoring, surgery if warranted) in infants with a localised suprarenal mass discovered ante or neonatally.
To determine the 3-year surgery-free survival in infants with suprarenal masses discovered ante or neonatally and managed conservatively (non initial surgery).
To find out the natural history of perinatal suprarenal masses, according to the definitions set up for the study.
To study the kinetics of regression in those suspected suprarenal neuroblastomas in infants with suprarenal masses discovered ante or neonatally and managed conservatively (non initial surgery).
To collect tissue from those suprarenal masses excised in order to perform standard and investigational pathological and biological studies (INPC, MYCN, 1p, 11).
To collect frozen plasma from all patients included in the study in order to perform research.
Full Information
NCT ID
NCT01728155
First Posted
November 13, 2012
Last Updated
September 5, 2023
Sponsor
Instituto de Investigacion Sanitaria La Fe
1. Study Identification
Unique Protocol Identification Number
NCT01728155
Brief Title
European Low and Intermediate Risk Neuroblastoma Protocol
Official Title
European Low and Intermediate Risk Neuroblastoma Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2011 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigacion Sanitaria La Fe
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The European study, LINES 2009 (Low and Intermediate Risk Neuroblastoma European Study), groups together in a single protocol the treatment of all patients with "non high risk" neuroblastoma (NB), with stratification into two groups: low risk and intermediate risk. These two separate cohorts are included in one single protocol to enable patient data from these two groups to be entered into a common database, as the current prognostic classifications determining treatment may evolve further with subsequent more detailed molecular analysis of the tumours.
1. LOW RISK STUDY
The Low Risk Study is proposed in order to:
minimise the amount of treatment (chemotherapy and surgery) for all appropriate low risk patients, who in previous studies have been shown to have an excellent long-term outcome (as in the SIOPEN 99.1-2 infant neuroblastoma studies where the overall survival was greater than 97%(H. Rubie, JCO).
improve the EFS and maintain the OS (overall survival) in L2 and Ms patients with a SCA(Segmental Cromosomal Aberration) genomic profile tumour (presence of any segmental chromosomal change (SCA)) by electively treating these patients with chemotherapy despite the absence of symptoms.
2) INTERMEDIATE RISK STUDY
The Intermediate Risk Study is proposed in order to:
reduce the amount of chemotherapy for differentiating histology INRG (International Neuroblastoma Risk Group) stage L2 NB and ganglioneuroblastoma nodular patients who in previous SIOPEN study have been shown to have an excellent long-term outcome;
increase the amount of treatment (radiotherapy and 13-cis-RA (13-cis-Retinoic Acid) for poorly differentiated or undifferentiated histology INRG stage L2 NB or ganglioneuroblastoma nodular patients in order to improve the EFS registered in the previous SIOPEN study;
improve the EFS (Event Free Survival) of MYCN (V-Myc myelocytomatosis viral related oncogene, NB derived ,avian )amplified INSS (International NB Staging System) stage 1 NB patients with the introduction of adjuvant treatment;
maintain the very good results obtained in previous SIOPEN study for INRG stage M infants with a moderate treatment.
NEONATAL SUPRARENAL MASSES
The incidence of suprarenal tumours/masses has increased in the last decade due to the expanded use of prenatal ultrasonography in routine obstetric care and in the neonatal and early infancy care. The differential diagnosis of these masses ranges from benign (adrenal haemorrhage) to malignant processes (neuroblastoma, adrenal carcinoma). Knowledge on perinatal suprarenal masses, although based on a relatively large literature, is scattered amongst studies on very few cases with no methodical approach and often short follow up. Therefore, the optimal management of these masses has not been clearly defined. Neuroblastoma at this age is an intriguing entity with a very good prognosis in most cases. The SIOPEN Group, based on their results in the first multicenter European Trial for infants with neuroblastoma (INES) and the world-wide experience provided in the literature, is launching this European surveillance study (Multi-centre, non-blinded, one armed prospective trial) for these masses. Treatment: Observation
Detailed Description
1. LOW RISK STUDY
The low risk group of patients includes NB patients without MYCN amplification with or without life threatening symptoms in the following clinical situations:
Children aged ≤ 18 months with localised neuroblastoma associated with image defined risk factors precluding upfront surgery (stage INRG L2).
Children aged ≤ 12 months with disseminated neuroblastoma without bone, pleura, lung or CNS (Central Nervous System) disease (stage INRG Ms)
2) INTERMEDIATE RISK STUDY
The intermediate risk group of patients includes NB patients in the following clinical situations:
Children aged >18 months with localised neuroblastoma without MYCN amplification, associated with image defined risk factors precluding upfront surgery (stage INRG L2).
Children aged ≤12 months with disseminated neuroblastoma involving bone, pleura, lung and/or CNS (stage INRG M), without MYCN amplification.
Children with localised resected NB (stage INSS I) with MYCN amplification. NEONATAL SUPRARENAL MASSES
The incidence of suprarenal tumours/masses has increased in the last decade due to the expanded use of prenatal ultrasonography in routine obstetric care and in the neonatal and early infancy care. The differential diagnosis of these masses ranges from benign (adrenal haemorrhage) to malignant processes (neuroblastoma, adrenal carcinoma). Knowledge on perinatal suprarenal masses, although based on a relatively large literature, is scattered amongst studies on very few cases with no methodical approach and often short follow up. Therefore, the optimal management of these masses has not been clearly defined. Neuroblastoma at this age is an intriguing entity with a very good prognosis in most cases. The SIOPEN Group, based on their results in the first multicenter European Trial for infants with neuroblastoma (INES) and the world-wide experience provided in the literature, is launching this European surveillance study (Multi-centre, non-blinded, one armed prospective trial) for these masses. Treatment: Observation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES
Keywords
NEUROBLASTOMA, LOW RISK, INTERMEDIATE RISK
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
685 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group1
Arm Type
No Intervention
Arm Description
initial observation (chemotherapy is only given if there is subsequent progression)
Arm Title
Group 1: chemotherapy
Arm Type
Active Comparator
Arm Description
chemotherapy and surgery
Arm Title
Group 2
Arm Type
Experimental
Arm Description
chemotherapy and surgery
Arm Title
Group 3
Arm Type
Experimental
Arm Description
chemotherapy and surgery
Arm Title
Group 4
Arm Type
No Intervention
Arm Description
Observation
Arm Title
Group 5
Arm Type
Experimental
Arm Description
chemotherapy
Arm Title
Group 6
Arm Type
Experimental
Arm Description
chemotherapy and surgery
Arm Title
Group 7
Arm Type
Experimental
Arm Description
chemotherapy and surgery
Arm Title
Group 8
Arm Type
Experimental
Arm Description
chemotherapy, surgery, radiotherapy and 13 cis-retinoic acid
Arm Title
Group 9
Arm Type
Experimental
Arm Description
chemotherapy, surgery, radiotherapy and 13 cis-retinoic acid
Arm Title
Group 10
Arm Type
Experimental
Arm Description
chemotherapy, surgery,
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Primary Outcome Measure Information:
Title
Primary aim for Low Risk Neuroblastoma
Description
To demonstrate through a randomisation between observation and chemotherapy that you can safely reduce treatment in a subgroup of L2 low risk patients (those without life threatening symptoms (LTS) and without any segmental chromosomal changes (SCA), i.e. study group 1) by giving less treatment than has been given historically while maintaining an excellent OS of 100%.
Time Frame
2 years
Title
Primary aim for Intermediate Risk Neuroblastoma
Description
To improve the EFS to 70% with an OS of 90% of INRG stage L2 patients over the age of 18 months, with poorly differentiated or undifferentiated tumour histology (INPC criteria), by the addition of radiotherapy and 13-cis RA compared to historical conventional treatment (study group 8).
Time Frame
2 years
Title
Primary Aim for Neonatal Suprarenal Masses
Description
To maintain a 3-year event free survival over 80% with a non-operative therapeutic approach (serial monitoring, surgery if warranted) in infants with a localised suprarenal mass discovered ante or neonatally.
Time Frame
3 year
Secondary Outcome Measure Information:
Title
To maintain a 2 year EFS of at least 90% and an OS of at least 95% in L2 patients with LTS without SCA (study group 2)
Time Frame
2 year
Title
To maintain the 2 year EFS of 85% and an OS of at least 98% in Ms patients without SCA (study groups 4 and 5)
Time Frame
2 year
Title
To improve the 2 year EFS to at least 90% and maintain the OS of close to 100% in L2 patients with SCA (Study Group 3) and improve the 2 year EFS to over 70% in Ms patients with SCA (study group 6)
Time Frame
2 year
Title
To evaluate adherence to the protocol recommendations regarding LTS
Time Frame
5 years
Title
To reduce surgical morbidity by promoting strict adherence to Image Defined-Risk Factors (IDRFs) to determine surgical resectability
Time Frame
5 year
Title
To define the long term follow-up and natural history of the Stage L2 non-resected masses that have remained IDRF positive at the end of treatment (study groups 1-3).
Time Frame
5 year
Title
To confirm in a larger patient cohort the excellent OS of 95% in stage M neuroblastoma without MYCN amplification, less than 12 months of age, when treated with moderate therapy (study group 10).
Time Frame
3 year
Title
Maintain the results of 3yr-EFS of 90% and 3yr-OS of 100% in stage L2 patients over the age of 18 months, with differentiating neuroblastoma or differentiating ganglioneuroblastoma nodular, despite a treatment reduction (group7)
Time Frame
3 year
Title
To improve the 3 year EFS to at least 50% and the 3 year OS to 80% in INSS stage I patients with MYCN amplified neuroblastoma by the addition of adjuvant treatment (study group 9).
Time Frame
3 year
Title
To evaluate the impact of the tumour genomic profile on patient outcome, in order to consider its role in the treatment stratification of these intermediate risk patients (all study groups).
Time Frame
5 years
Title
To manage infants with suprarenal masses discovered ante or neonatally with a uniform approach in Europe in a multicentre setting.
Time Frame
5 years
Title
To maintain an excellent overall survival with a non-operative therapeutic approach (serial monitoring, surgery if warranted) in infants with a localised suprarenal mass discovered ante or neonatally.
Time Frame
3 years
Title
To determine the 3-year surgery-free survival in infants with suprarenal masses discovered ante or neonatally and managed conservatively (non initial surgery).
Time Frame
3 years
Title
To find out the natural history of perinatal suprarenal masses, according to the definitions set up for the study.
Time Frame
5 years
Title
To study the kinetics of regression in those suspected suprarenal neuroblastomas in infants with suprarenal masses discovered ante or neonatally and managed conservatively (non initial surgery).
Time Frame
5 years
Title
To collect tissue from those suprarenal masses excised in order to perform standard and investigational pathological and biological studies (INPC, MYCN, 1p, 11).
Time Frame
5 years
Title
To collect frozen plasma from all patients included in the study in order to perform research.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
90 Days
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
LOW RISK STUDY
Inclusion criteria for the whole low risk group:
informed consent and follow-up warranted; group assignment completed within 6 weeks from diagnosis; no prior chemotherapy or radiotherapy
Biopsy proven neuroblastoma
Tumour genomic profile obtained in a NRL according to guidelines
MYCN non-amplified
Exclusion criteria for the whole low risk group:
* Diagnosis of ganglioneuroma or ganglioneuroblastoma intermixed INRG Stage L2
Inclusion criteria:
*age ≤ 18 months
Exclusion criteria:
any metastatic site
MYCN amplification
age > 18 months INRG Stage Ms
Inclusion criteria:
* age ≤ 12 months
Exclusion criteria:
bone, pleura/lung and/or CNS metastasis
MYCN amplification
age > 12 months
INTERMEDIATE RISK STUDY
Inclusion criteria for the whole intermediate risk group:
informed consent and follow-up warranted; group assignment completed within 6 weeks from diagnosis; no prior chemotherapy or radiotherapy
Tumour material available for biological studies according to guidelines
Biopsy proven neuroblastoma confirmed in a National Reference Laboratory (NRL)
Exclusion criteria for the whole intermediate risk group:
* Diagnosis of ganglioneuroma or ganglioneuroblastoma intermixed
INRG Stage L1 and INSS stage 1:
Inclusion criteria:
* MYCN amplified
Exclusion criteria:
MYCN non-amplified
INSS stages 2, 3, 4, 4s
INRG Stage L2:
Inclusion criteria:
Histology: differentiating, poorly differentiated, undifferentiated neuroblastoma or ganglioneuroblastoma nodular
MYCN non-amplified
age >18 months
Exclusion criteria:
neuroblastoma NOS
MYCN amplification.
age ≤ 18 months
INRG Stage M:
Inclusion criteria:
Any histology
MYCN non-amplified
age ≤ 12 months
Exclusion criteria:
MYCN amplification
age > 12 months
NEONATAL SUPRARENAL MASSES
Inclusion criteria:
Age less than or equal to 90 days when the suprarenal mass is discovered.
Suprarenal mass detected by ultrasound and/or MRI. The suprarenal mass may be cystic and/or solid, but IT CANNOT REACH THE MIDLINE AND should MEASURE ≤ 5 CM AT THE LARGEST DIAMETER.
No regional involvement: MRI scan does not show evidence of positive ipsi/contralateral lymph nodes or other spread outside the suprarenal gland.
No metastatic involvement.
Frozen plasma available.
Informed consent.
Availability to do the adequate follow-up
Exclusion criteria:
Age older than 90 days.
Suprarenal mass bigger than 5 cm.
Regional involvement.
Metastatic involvement.
Inability to undertake mandatory diagnostic studies (biological markers, US, MRI, MIBG).
Follow-up not guaranteed by parents/guardians.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adela Cañete, MD, PhD
Organizational Affiliation
Hospital Universitari i Politècnic La Fe, Valencia, Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gudrun Schleiermacher
Organizational Affiliation
Institut Curie
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kate Wheeler
Organizational Affiliation
Oxford: John Radcliffe Hospital, UK
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andrea di Cataldo
Organizational Affiliation
Policlinico Universitario, Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vassilius Papadakis
Organizational Affiliation
Aghia Sophia Children's Hospital, Athens
Official's Role
Study Chair
Facility Information:
Facility Name
Monash Children's Hospital
City
Clayton
Country
Australia
Facility Name
Perth Children's Hospital
City
Nedlands
Country
Australia
Facility Name
Sydney Children's Hospital
City
Sydney
Country
Australia
Facility Name
PHO Med Uni Graz
City
Graz
Country
Austria
Facility Name
Department Kinder- und Jugendheilkunde
City
Innsbruck
Country
Austria
Facility Name
Landes-Frauen- und Kinderklinik Linz
City
Linz
Country
Austria
Facility Name
St. Anna Kinderspital
City
Wien
Country
Austria
Facility Name
Univ Klinik für Kinder- und Jugendheilkunde
City
Wien
Country
Austria
Facility Name
Hôpital Universitaire d'Anvers (UZA- Universitair Ziekenhuis Antwerpen)
City
Antwerpen
Country
Belgium
Facility Name
Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
City
Bruxelles
Country
Belgium
Facility Name
UCL Clíniques Universitaires Saint - Luc
City
Bruxelles
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Bruxelles
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
Country
Belgium
Facility Name
CHC- Clinique de l'Espérance à Liège
City
Liège
Country
Belgium
Facility Name
CHR de la Citadelle
City
Liège
Country
Belgium
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Facility Name
National State Hospital (Department of Pediatrics)
City
Copenhagen
Country
Denmark
Facility Name
University Hospital of Odense (H.C. Andersen Children´s Hospital)
City
Odense
Country
Denmark
Facility Name
Soroka Medical Center
City
Beersheba
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel
Facility Name
Schneider Children's Medical Center
City
Petah Tikva
Country
Israel
Facility Name
Ichilov Hospital Sourasky Medical Center
City
Tel aviv
Country
Israel
Facility Name
Ospedale Pediatrico G. Salesi di Ancona (Centro Regionale Oncoematologia Pediatrica)
City
Ancona
Country
Italy
Facility Name
Azienda Ospedaliera - Universitaria Ospedale Policlinico Consorziale
City
Bari
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti di Bergamo
City
Bergamo
Country
Italy
Facility Name
Azienda Ospedaliero- Universitaria di Bologna- Policlinico S. Orsola - Malpighi
City
Bologna
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
Country
Italy
Facility Name
Ospedale Microcitemico
City
Cagliari
Country
Italy
Facility Name
Oncology Policlinico- Department of Hematology
City
Catania
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Ferrara- Oncoematologia Pediatrica
City
Ferrara
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Ospedale Pediatrico Meyer
City
Firenze
Country
Italy
Facility Name
Oncology Gaslini Children's Hospital of Genova- Department of Hematology
City
Genova
Country
Italy
Facility Name
Istituto Nazionale dei Tumori di Milano- Onco-ematologia Pediatrica
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Policlinico di Modena- Onco-ematologia Pediatrica
City
Modena
Country
Italy
Facility Name
Azienda Ospedaliera Pediatrica Santobono Pausilipon
City
Napoli
Country
Italy
Facility Name
Sec. Università degli studi di Napoli - Policlinico
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera-Universitaria di Padova- Clínica di Onco-ematologia Pediatrica
City
Padova
Country
Italy
Facility Name
Ospedale dei Bambini G. Di Cristina
City
Palermo
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria di Parma- Oncoematologia Pediatrica
City
Parma
Country
Italy
Facility Name
Fondazione IRCCS - Policlinico San Matteo - Oncoematologia Pediadrica
City
Pavia
Country
Italy
Facility Name
Azienda USL Di Pescara - U.O.C di Ematologia Clinica
City
Pescara
Country
Italy
Facility Name
Ospedale Infermi di Rimini - U.O. Pediatria
City
Rimini
Country
Italy
Facility Name
Ospedale Pediatrico Bambino Gesù- Oncoematologia pediatrica
City
Roma
Country
Italy
Facility Name
Ospedale Policlinico Universitario Agostino Gemelli
City
Roma
Country
Italy
Facility Name
Policlinico Umberto I
City
Roma
Country
Italy
Facility Name
Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese - Clinica Pediatrica
City
Siena
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera O.I.R.M.- Sant' Anna
City
Torino
Country
Italy
Facility Name
Ospedale Cardinale G. Panico
City
Tricase
Country
Italy
Facility Name
Ospedale Infantile Burlo Garofolo ( U.O. Emato-Oncologia Pediatrica - Università degli studi di Trieste)
City
Trieste
Country
Italy
Facility Name
Policlinico G.B. Rossi- Oncoematologia Pediatrica
City
Verona
Country
Italy
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway
Facility Name
Oslo University Hospital, Rikshospitalet. (National coordinator)
City
Oslo
Country
Norway
Facility Name
University Hospital of Northern Norway
City
Tromsø
Country
Norway
Facility Name
St Olavs University Hospital
City
Trondheim
Country
Norway
Facility Name
Hospital de Sabadell
City
Sabadell
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Universitario Montepríncipe
City
Boadilla del Monte
State/Province
Madrid
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
La Laguna
State/Province
Tenerife
Country
Spain
Facility Name
Hospital General Universitario de Albacete
City
Albacete
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
Country
Spain
Facility Name
Complejo Hospitalario Torrecárdenas
City
Almería
Country
Spain
Facility Name
Hospital Infanta Cristina
City
Badajoz
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Materno Infantil Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Cruces
City
Bilbao
Country
Spain
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
Country
Spain
Facility Name
Hospital Universitario Materno Infantil Virgen de las Nieves
City
Granada
Country
Spain
Facility Name
Hospital Materno Infantil de Jaén
City
Jaén
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Infantil la Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Infantil Niño Jesús
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya - Hospital Materno Infantil
City
Málaga
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
Country
Spain
Facility Name
Hospital Virgen del Camino
City
Pamplona
Country
Spain
Facility Name
Hospital Universitario Donostia
City
San Sebastián
Country
Spain
Facility Name
Hospital Universitario de Santiago
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
Country
Spain
Facility Name
Instituto de Investigacion Sanitaria La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Clínic Universitari
City
València
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
Country
Spain
Facility Name
Queen Silvia's Children's Hospital
City
Göteborg
Country
Sweden
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden
Facility Name
Skåne University Hospital
City
Lund
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Facility Name
Norrlands University Hospital
City
Umeå
Country
Sweden
Facility Name
Uppsala Academic Children's Hospital
City
Uppsala
Country
Sweden
Facility Name
Kantonsspital Aarau
City
Aarau
Country
Switzerland
Facility Name
Universitäts-Kinderspital beider Basel
City
Basel
Country
Switzerland
Facility Name
Ospedale San Giovanni
City
Bellinzona
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
Country
Switzerland
Facility Name
HUG Hôpitaux Universitaires Genève
City
Genève
Country
Switzerland
Facility Name
CHUV - Centre Hospitalier Universitaire Vaudois - Unité d'hémato-oncologie pédiatrique
City
Lausanne
Country
Switzerland
Facility Name
Luzerner Kantonsspital
City
Lucerne
Country
Switzerland
Facility Name
Ostschweizer Kinderspital
City
St. Gallen
Country
Switzerland
Facility Name
Universitäts-Kinderspital Zürich
City
Zürich
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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https://www.siope.eu/activities/eu-projects/encca/
Description
The European Network for Cancer Research in Children and Adolescents (ENCCA) is a Network of Excellence Funded by the European Union's 7th Framework Programme (FP7): See WP10
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European Low and Intermediate Risk Neuroblastoma Protocol
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