European Low and Intermediate Risk Neuroblastoma Protocol

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

Study Overview

• Status: Completed
• Conditions: LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES
• Intervention / Treatment: Drug: chemotherapy

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

• Study Type: Interventional
• Enrollment (Actual): 685
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Clayton, Australia
    • Monash Children's Hospital
  • Nedlands, Australia
    • Perth Children's Hospital
  • Sydney, Australia
    • Sydney Children's Hospital
• Austria
  • Graz, Austria
    • PHO Med Uni Graz
  • Innsbruck, Austria
    • Department Kinder- und Jugendheilkunde
  • Linz, Austria
    • Landes-Frauen- und Kinderklinik Linz
  • Wien, Austria
    • St. Anna Kinderspital
  • Wien, Austria
    • Univ Klinik für Kinder- und Jugendheilkunde
• Belgium
  • Antwerpen, Belgium
    • Hôpital Universitaire d'Anvers (UZA- Universitair Ziekenhuis Antwerpen)
  • Bruxelles, Belgium
    • Universitair Ziekenhuis Brussel
  • Bruxelles, Belgium
    • Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
  • Bruxelles, Belgium
    • UCL Clíniques Universitaires Saint - Luc
  • Gent, Belgium
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium
    • Universitair Ziekenhuis Leuven
  • Liège, Belgium
    • CHR de la Citadelle
  • Liège, Belgium
    • CHC- Clinique de l'Espérance à Liège
• Denmark
  • Aarhus, Denmark
    • Aarhus University Hospital
  • Copenhagen, Denmark
    • National State Hospital (Department of Pediatrics)
  • Odense, Denmark
    • University Hospital of Odense (H.C. Andersen Children´s Hospital)
• Israel
  • Beersheba, Israel
    • Soroka Medical Center
  • Haifa, Israel
    • Rambam Health Care Campus
  • Petah Tikva, Israel
    • Schneider Children's Medical Center
  • Tel aviv, Israel
    • Ichilov Hospital Sourasky Medical Center
• Italy
  • Ancona, Italy
    • Ospedale Pediatrico G. Salesi di Ancona (Centro Regionale Oncoematologia Pediatrica)
  • Bari, Italy
    • Azienda Ospedaliera - Universitaria Ospedale Policlinico Consorziale
  • Bergamo, Italy
    • Azienda Ospedaliera Ospedali Riuniti di Bergamo
  • Bologna, Italy
    • Azienda Ospedaliero- Universitaria di Bologna- Policlinico S. Orsola - Malpighi
  • Brescia, Italy
    • Azienda Ospedaliera Spedali Civili di Brescia
  • Cagliari, Italy
    • Ospedale Microcitemico
  • Catania, Italy
    • Oncology Policlinico- Department of Hematology
  • Ferrara, Italy
    • Azienda Ospedaliero-Universitaria di Ferrara- Oncoematologia Pediatrica
  • Firenze, Italy
    • Azienda Ospedaliero-Universitaria Ospedale Pediatrico Meyer
  • Genova, Italy
    • Oncology Gaslini Children's Hospital of Genova- Department of Hematology
  • Milano, Italy
    • Istituto Nazionale dei Tumori di Milano- Onco-ematologia Pediatrica
  • Modena, Italy
    • Azienda Ospedaliero-Universitaria Policlinico di Modena- Onco-ematologia Pediatrica
  • Napoli, Italy
    • Azienda Ospedaliera Pediatrica Santobono Pausilipon
  • Napoli, Italy
    • Sec. Università degli studi di Napoli - Policlinico
  • Padova, Italy
    • Azienda Ospedaliera-Universitaria di Padova- Clínica di Onco-ematologia Pediatrica
  • Palermo, Italy
    • Ospedale dei Bambini G. Di Cristina
  • Parma, Italy
    • Azienda Ospedaliero - Universitaria di Parma- Oncoematologia Pediatrica
  • Pavia, Italy
    • Fondazione IRCCS - Policlinico San Matteo - Oncoematologia Pediadrica
  • Pescara, Italy
    • Azienda USL Di Pescara - U.O.C di Ematologia Clinica
  • Rimini, Italy
    • Ospedale Infermi di Rimini - U.O. Pediatria
  • Roma, Italy
    • Policlinico Umberto I
  • Roma, Italy
    • Ospedale Pediatrico Bambino Gesù- Oncoematologia pediatrica
  • Roma, Italy
    • Ospedale Policlinico Universitario Agostino Gemelli
  • San Giovanni Rotondo, Italy
    • Casa Sollievo della Sofferenza
  • Siena, Italy
    • Azienda Ospedaliera Universitaria Senese - Clinica Pediatrica
  • Torino, Italy
    • Azienda Sanitaria Ospedaliera O.I.R.M.- Sant' Anna
  • Tricase, Italy
    • Ospedale Cardinale G. Panico
  • Trieste, Italy
    • Ospedale Infantile Burlo Garofolo ( U.O. Emato-Oncologia Pediatrica - Università degli studi di Trieste)
  • Verona, Italy
    • Policlinico G.B. Rossi- Oncoematologia Pediatrica
• Norway
  • Bergen, Norway
    • Haukeland University Hospital
  • Oslo, Norway
    • Oslo University Hospital, Rikshospitalet. (National coordinator)
  • Tromsø, Norway
    • University Hospital of Northern Norway
  • Trondheim, Norway
    • St Olavs University Hospital
• Spain
  • Albacete, Spain
    • Hospital General Universitario de Albacete
  • Alicante, Spain
    • Hospital General Universitario de Alicante
  • Almería, Spain
    • Complejo Hospitalario Torrecárdenas
  • Badajoz, Spain
    • Hospital Infanta Cristina
  • Barcelona, Spain
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain
    • Hospital Materno Infantil Vall d'Hebron
  • Bilbao, Spain
    • Hospital Universitario Cruces
  • Córdoba, Spain
    • Hospital Universitario Reina Sofia
  • Granada, Spain
    • Hospital Universitario Materno Infantil Virgen de las Nieves
  • Jaén, Spain
    • Hospital Materno Infantil de Jaén
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain
    • Hospital Universitario Infantil LA PAZ
  • Madrid, Spain
    • Hospital Universitario Infantil Nino Jesus
  • Murcia, Spain
    • Hospital Universitario Virgen de La Arrixaca
  • Málaga, Spain
    • Hospital Regional Universitario Carlos Haya - Hospital Materno Infantil
  • Oviedo, Spain
    • Hospital Universitario Central de Asturias
  • Pamplona, Spain
    • Hospital Virgen del Camino
  • San Sebastián, Spain
    • Hospital Universitario Donostia
  • Santiago de Compostela, Spain
    • Hospital Universitario de Santiago
  • Sevilla, Spain
    • Hospital Universitario Virgen del Rocio
  • Sevilla, Spain
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46009
    • Instituto de Investigacion Sanitaria La Fe
  • València, Spain
    • Hospital Clinic Universitari
  • Zaragoza, Spain
    • Hospital Universitario Miguel Servet
  • Barcelona
    • Sabadell, Barcelona, Spain
      • Hospital de Sabadell
  • Madrid
    • Boadilla del Monte, Madrid, Spain
      • Hospital Universitario Montepríncipe
  • Tenerife
    • La Laguna, Tenerife, Spain
      • Hospital Universitario de Canarias
• Sweden
  • Göteborg, Sweden
    • Queen Silvia's Children's Hospital
  • Linköping, Sweden
    • Linkoping University Hospital
  • Lund, Sweden
    • Skane University Hospital
  • Stockholm, Sweden
    • Karolinska University Hospital
  • Umeå, Sweden
    • Norrlands University Hospital
  • Uppsala, Sweden
    • Uppsala Academic Children's Hospital
• Switzerland
  • Aarau, Switzerland
    • Kantonsspital Aarau
  • Basel, Switzerland
    • Universitäts-Kinderspital beider Basel
  • Bellinzona, Switzerland
    • Ospedale San Giovanni
  • Bern, Switzerland
    • Inselspital Bern
  • Genève, Switzerland
    • HUG Hôpitaux Universitaires Genève
  • Lausanne, Switzerland
    • CHUV - Centre Hospitalier Universitaire Vaudois - Unité d'hémato-oncologie pédiatrique
  • Lucerne, Switzerland
    • Luzerner Kantonsspital
  • St. Gallen, Switzerland
    • Ostschweizer Kinderspital
  • Zürich, Switzerland
    • Universitäts-Kinderspital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

1. 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

2. 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
3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group1; initial observation (chemotherapy is only given if there is subsequent progression)
Active Comparator: Group 1: chemotherapy; chemotherapy and surgery	Drug: chemotherapy
Experimental: Group 2; chemotherapy and surgery	Drug: chemotherapy
Experimental: Group 3; chemotherapy and surgery	Drug: chemotherapy
No Intervention: Group 4; Observation
Experimental: Group 5; chemotherapy	Drug: chemotherapy
Experimental: Group 6; chemotherapy and surgery	Drug: chemotherapy
Experimental: Group 7; chemotherapy and surgery	Drug: chemotherapy
Experimental: Group 8; chemotherapy, surgery, radiotherapy and 13 cis-retinoic acid	Drug: chemotherapy
Experimental: Group 9; chemotherapy, surgery, radiotherapy and 13 cis-retinoic acid	Drug: chemotherapy
Experimental: Group 10; chemotherapy, surgery,	Drug: chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	2 years
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).	2 years
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.	3 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	2 year
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)	2 year
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)	2 year
To evaluate adherence to the protocol recommendations regarding LTS	5 years
To reduce surgical morbidity by promoting strict adherence to Image Defined-Risk Factors (IDRFs) to determine surgical resectability	5 year
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).	5 year
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).	3 year
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)	3 year
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).	3 year
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).	5 years
To manage infants with suprarenal masses discovered ante or neonatally with a uniform approach in Europe in a multicentre setting.	5 years
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.	3 years
To determine the 3-year surgery-free survival in infants with suprarenal masses discovered ante or neonatally and managed conservatively (non initial surgery).	3 years
To find out the natural history of perinatal suprarenal masses, according to the definitions set up for the study.	5 years
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).	5 years
To collect tissue from those suprarenal masses excised in order to perform standard and investigational pathological and biological studies (INPC, MYCN, 1p, 11).	5 years
To collect frozen plasma from all patients included in the study in order to perform research.	5 years

Collaborators and Investigators

• Sponsor: Instituto de Investigacion Sanitaria La Fe
• Investigators: Study Chair: Adela Cañete, MD, PhD, Hospital Universitari i Politècnic La Fe, Valencia, Spain; Study Chair: Gudrun Schleiermacher, Institut Curie; Study Chair: Kate Wheeler, Oxford: John Radcliffe Hospital, UK; Study Chair: Andrea di Cataldo, Policlinico Universitario, Italy; Study Chair: Vassilius Papadakis, Aghia Sophia Children's Hospital, Athens

Publications and helpful links

General Publications

• Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
• Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.
• Monclair T, Brodeur GM, Ambros PF, Brisse HJ, Cecchetto G, Holmes K, Kaneko M, London WB, Matthay KK, Nuchtern JG, von Schweinitz D, Simon T, Cohn SL, Pearson AD; INRG Task Force. The International Neuroblastoma Risk Group (INRG) staging system: an INRG Task Force report. J Clin Oncol. 2009 Jan 10;27(2):298-303. doi: 10.1200/JCO.2008.16.6876. Epub 2008 Dec 1.
• Brodeur GM, Pritchard J, Berthold F, Carlsen NL, Castel V, Castelberry RP, De Bernardi B, Evans AE, Favrot M, Hedborg F, et al. Revisions of the international criteria for neuroblastoma diagnosis, staging, and response to treatment. J Clin Oncol. 1993 Aug;11(8):1466-77. doi: 10.1200/JCO.1993.11.8.1466.
• Cohn SL, Pearson AD, London WB, Monclair T, Ambros PF, Brodeur GM, Faldum A, Hero B, Iehara T, Machin D, Mosseri V, Simon T, Garaventa A, Castel V, Matthay KK; INRG Task Force. The International Neuroblastoma Risk Group (INRG) classification system: an INRG Task Force report. J Clin Oncol. 2009 Jan 10;27(2):289-97. doi: 10.1200/JCO.2008.16.6785. Epub 2008 Dec 1.
• De Bernardi B, Gerrard M, Boni L, Rubie H, Canete A, Di Cataldo A, Castel V, Forjaz de Lacerda A, Ladenstein R, Ruud E, Brichard B, Couturier J, Ellershaw C, Munzer C, Bruzzi P, Michon J, Pearson AD. Excellent outcome with reduced treatment for infants with disseminated neuroblastoma without MYCN gene amplification. J Clin Oncol. 2009 Mar 1;27(7):1034-40. doi: 10.1200/JCO.2008.17.5877. Epub 2009 Jan 26.
• Janoueix-Lerosey I, Schleiermacher G, Michels E, Mosseri V, Ribeiro A, Lequin D, Vermeulen J, Couturier J, Peuchmaur M, Valent A, Plantaz D, Rubie H, Valteau-Couanet D, Thomas C, Combaret V, Rousseau R, Eggert A, Michon J, Speleman F, Delattre O. Overall genomic pattern is a predictor of outcome in neuroblastoma. J Clin Oncol. 2009 Mar 1;27(7):1026-33. doi: 10.1200/JCO.2008.16.0630. Epub 2009 Jan 26.
• Schleiermacher G, Michon J, Huon I, d'Enghien CD, Klijanienko J, Brisse H, Ribeiro A, Mosseri V, Rubie H, Munzer C, Thomas C, Valteau-Couanet D, Auvrignon A, Plantaz D, Delattre O, Couturier J; Societe Francaise des Cancers de l'Enfant (SFCE). Chromosomal CGH identifies patients with a higher risk of relapse in neuroblastoma without MYCN amplification. Br J Cancer. 2007 Jul 16;97(2):238-46. doi: 10.1038/sj.bjc.6603820. Epub 2007 Jun 19.
• Cecchetto G, Mosseri V, De Bernardi B, Helardot P, Monclair T, Costa E, Horcher E, Neuenschwander S, Toma P, Rizzo A, Michon J, Holmes K. Surgical risk factors in primary surgery for localized neuroblastoma: the LNESG1 study of the European International Society of Pediatric Oncology Neuroblastoma Group. J Clin Oncol. 2005 Nov 20;23(33):8483-9. doi: 10.1200/JCO.2005.02.4661.
• De Bernardi B, Mosseri V, Rubie H, Castel V, Foot A, Ladenstein R, Laureys G, Beck-Popovic M, de Lacerda AF, Pearson AD, De Kraker J, Ambros PF, de Rycke Y, Conte M, Bruzzi P, Michon J; SIOP Europe Neuroblastoma Group. Treatment of localised resectable neuroblastoma. Results of the LNESG1 study by the SIOP Europe Neuroblastoma Group. Br J Cancer. 2008 Oct 7;99(7):1027-33. doi: 10.1038/sj.bjc.6604640. Epub 2008 Sep 2.
• Bagatell R, Beck-Popovic M, London WB, Zhang Y, Pearson AD, Matthay KK, Monclair T, Ambros PF, Cohn SL; International Neuroblastoma Risk Group. Significance of MYCN amplification in international neuroblastoma staging system stage 1 and 2 neuroblastoma: a report from the International Neuroblastoma Risk Group database. J Clin Oncol. 2009 Jan 20;27(3):365-70. doi: 10.1200/JCO.2008.17.9184. Epub 2008 Dec 1.
• Canete A, Gerrard M, Rubie H, Castel V, Di Cataldo A, Munzer C, Ladenstein R, Brichard B, Bermudez JD, Couturier J, de Bernardi B, Pearson AJ, Michon J. Poor survival for infants with MYCN-amplified metastatic neuroblastoma despite intensified treatment: the International Society of Paediatric Oncology European Neuroblastoma Experience. J Clin Oncol. 2009 Mar 1;27(7):1014-9. doi: 10.1200/JCO.2007.14.5839. Epub 2009 Jan 26.
• Hero B, Simon T, Spitz R, Ernestus K, Gnekow AK, Scheel-Walter HG, Schwabe D, Schilling FH, Benz-Bohm G, Berthold F. Localized infant neuroblastomas often show spontaneous regression: results of the prospective trials NB95-S and NB97. J Clin Oncol. 2008 Mar 20;26(9):1504-10. doi: 10.1200/JCO.2007.12.3349.
• Rubie H, Michon J, Plantaz D, Peyroulet MC, Coze C, Frappaz D, Chastagner P, Baranzelli MC, Mechinaud F, Boutard P, Lutz P, Perel Y, Leverger G, de Lumley L, Millot F, Stephan JL, Margueritte G, Hartmann O. Unresectable localized neuroblastoma: improved survival after primary chemotherapy including carboplatin-etoposide. Neuroblastoma Study Group of the Societe Francaise d'Oncologie Pediatrique (SFOP). Br J Cancer. 1998 Jun;77(12):2310-7. doi: 10.1038/bjc.1998.384.
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Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): December 31, 2022
• Study Completion: December 1, 2031

Study Registration Dates

• First Submitted: November 13, 2012
• First Submitted That Met QC Criteria: November 13, 2012
• First Posted (Estimated): November 16, 2012

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: NEUROBLASTOMA, LOW RISK, INTERMEDIATE RISK
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors, Primitive, Peripheral; Neuroblastoma
• Other Study ID Numbers: LINES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO