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AzTrials

LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSESPhase 3NCT01728155

European Low and Intermediate Risk Neuroblastoma Protocol

A Phase 3 study testing chemotherapy in people with LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES, run by Instituto de Investigacion Sanitaria La Fe at 98 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 90 days to 18 years
What is being tested?
chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
685 participants
Where
98 sitesin 10 countries
Study dates
1 Jan 2011to 31 Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 90 days to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
  • age ≤ 18 months
  • age ≤ 12 months
Show all 23Show fewer
  • 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)
  • MYCN amplified
  • Histology: differentiating, poorly differentiated, undifferentiated neuroblastoma or ganglioneuroblastoma nodular
  • MYCN non-amplified
  • age >18 months
  • Any histology
  • MYCN non-amplified
  • age ≤ 12 months
  • 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

Who cannot join

  • Diagnosis of ganglioneuroma or ganglioneuroblastoma intermixed INRG Stage L2
  • any metastatic site
  • MYCN amplification
  • age > 18 months INRG Stage Ms
  • bone, pleura/lung and/or CNS metastasis
  • MYCN amplification
Show all 26Show fewer
  • age > 12 months
  • INTERMEDIATE RISK STUDY
  • Diagnosis of ganglioneuroma or ganglioneuroblastoma intermixed
  • INRG Stage L1 and INSS stage 1:
  • MYCN non-amplified
  • INSS stages 2, 3, 4, 4s
  • INRG Stage L2:
  • neuroblastoma NOS
  • MYCN amplification.
  • age ≤ 18 months
  • INRG Stage M:
  • MYCN amplification
  • age > 12 months
  • NEONATAL SUPRARENAL MASSES
  • 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.

Trial locations and contacts

98 sites in 10 countries.

98 sites in 10 countries

Italy29 sites

  • Ospedale Pediatrico G. Salesi di Ancona (Centro Regionale Oncoematologia Pediatrica)

    Ancona

  • Azienda Ospedaliera - Universitaria Ospedale Policlinico Consorziale

    Bari

  • Azienda Ospedaliera Ospedali Riuniti di Bergamo

    Bergamo

  • Azienda Ospedaliero- Universitaria di Bologna- Policlinico S. Orsola - Malpighi

    Bologna

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia

  • Ospedale Microcitemico

    Cagliari

  • Oncology Policlinico- Department of Hematology

    Catania

  • Azienda Ospedaliero-Universitaria di Ferrara- Oncoematologia Pediatrica

    Ferrara

  • Azienda Ospedaliero-Universitaria Ospedale Pediatrico Meyer

    Florence

  • Oncology Gaslini Children's Hospital of Genova- Department of Hematology

    Genova

  • Istituto Nazionale dei Tumori di Milano- Onco-ematologia Pediatrica

    Milan

  • Azienda Ospedaliero-Universitaria Policlinico di Modena- Onco-ematologia Pediatrica

    Modena

  • Azienda Ospedaliera Pediatrica Santobono Pausilipon

    Naples

  • Sec. Università degli studi di Napoli - Policlinico

    Naples

  • Azienda Ospedaliera-Universitaria di Padova- Clínica di Onco-ematologia Pediatrica

    Padova

  • Ospedale dei Bambini G. Di Cristina

    Palermo

  • Azienda Ospedaliero - Universitaria di Parma- Oncoematologia Pediatrica

    Parma

  • Fondazione IRCCS - Policlinico San Matteo - Oncoematologia Pediadrica

    Pavia

  • Azienda USL Di Pescara - U.O.C di Ematologia Clinica

    Pescara

  • Ospedale Infermi di Rimini - U.O. Pediatria

    Rimini

  • Ospedale Pediatrico Bambino Gesù- Oncoematologia pediatrica

    Roma

  • Ospedale Policlinico Universitario Agostino Gemelli

    Roma

  • Policlinico Umberto I

    Roma

  • Casa Sollievo della Sofferenza

    San Giovanni Rotondo

  • Azienda Ospedaliera Universitaria Senese - Clinica Pediatrica

    Siena

  • Azienda Sanitaria Ospedaliera O.I.R.M.- Sant' Anna

    Torino

  • Ospedale Cardinale G. Panico

    Tricase

  • Ospedale Infantile Burlo Garofolo ( U.O. Emato-Oncologia Pediatrica - Università degli studi di Trieste)

    Trieste

  • Policlinico G.B. Rossi- Oncoematologia Pediatrica

    Verona

Other trials in Italy

Spain27 sites

  • Hospital General Universitario de Albacete

    Albacete

  • Hospital General Universitario de Alicante

    Alicante

  • Complejo Hospitalario Torrecárdenas

    Almería

  • Hospital Infanta Cristina

    Badajoz

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital Materno Infantil Vall d'Hebron

    Barcelona

  • Hospital Universitario Cruces

    Bilbao

  • Hospital Universitario Montepríncipe

    Boadilla del Monte, Madrid

  • Hospital Universitario Reina Sofía

    Córdoba

  • Hospital Universitario Materno Infantil Virgen de las Nieves

    Granada

  • Hospital Materno Infantil de Jaén

    Jaén

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Infantil la Paz

    Madrid

  • Hospital Universitario Infantil Niño Jesús

    Madrid

  • Hospital Regional Universitario Carlos Haya - Hospital Materno Infantil

    Málaga

  • Hospital Universitario Virgen de la Arrixaca

    Murcia

  • Hospital Universitario Central de Asturias

    Oviedo

  • Hospital Virgen del Camino

    Pamplona

  • Hospital de Sabadell

    Sabadell, Barcelona

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife

  • Hospital Universitario Donostia

    San Sebastián

  • Hospital Universitario de Santiago

    Santiago de Compostela

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Universitario Virgen Macarena

    Seville

  • Instituto de Investigacion Sanitaria La Fe

    Valencia, 46009

  • Hospital Clínic Universitari

    Valencia

  • Hospital Universitario Miguel Servet

    Zaragoza

Other trials in Spain

Switzerland9 sites

  • Kantonsspital Aarau

    Aarau

  • Universitäts-Kinderspital beider Basel

    Basel

  • Ospedale San Giovanni

    Bellinzona

  • Inselspital Bern

    Bern

  • HUG Hôpitaux Universitaires Genève

    Geneva

  • CHUV - Centre Hospitalier Universitaire Vaudois - Unité d'hémato-oncologie pédiatrique

    Lausanne

  • Luzerner Kantonsspital

    Lucerne

  • Ostschweizer Kinderspital

    Sankt Gallen

  • Universitäts-Kinderspital Zürich

    Zurich

Other trials in Switzerland

Belgium8 sites

  • Hôpital Universitaire d'Anvers (UZA- Universitair Ziekenhuis Antwerpen)

    Antwerp

  • Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)

    Brussels

  • UCL Clíniques Universitaires Saint - Luc

    Brussels

  • Universitair Ziekenhuis Brussel

    Brussels

  • Universitair Ziekenhuis Gent

    Ghent

  • Universitair Ziekenhuis Leuven

    Leuven

  • CHC- Clinique de l'Espérance à Liège

    Liège

  • CHR de la Citadelle

    Liège

Other trials in Belgium

Sweden6 sites

  • Queen Silvia's Children's Hospital

    Gothenburg

  • Linköping University Hospital

    Linköping

  • Skåne University Hospital

    Lund

  • Karolinska University Hospital

    Stockholm

  • Norrlands University Hospital

    Umeå

  • Uppsala Academic Children's Hospital

    Uppsala

Other trials in Sweden

Austria5 sites

  • PHO Med Uni Graz

    Graz

  • Department Kinder- und Jugendheilkunde

    Innsbruck

  • Landes-Frauen- und Kinderklinik Linz

    Linz

  • St. Anna Kinderspital

    Vienna

  • Univ Klinik für Kinder- und Jugendheilkunde

    Vienna

Other trials in Austria

Israel4 sites

  • Soroka Medical Center

    Beersheba

  • Rambam Health Care Campus

    Haifa

  • Schneider Children's Medical Center

    Petah Tikva

  • Ichilov Hospital Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Norway4 sites

  • Haukeland University Hospital

    Bergen

  • Oslo University Hospital, Rikshospitalet. (National coordinator)

    Oslo

  • University Hospital of Northern Norway

    Tromsø

  • St Olavs University Hospital

    Trondheim

Other trials in Norway

Australia3 sites

  • Monash Children's Hospital

    Clayton

  • Perth Children's Hospital

    Nedlands

  • Sydney Children's Hospital

    Sydney

Other trials in Australia

Denmark3 sites

  • Aarhus University Hospital

    Aarhus

  • National State Hospital (Department of Pediatrics)

    Copenhagen

  • University Hospital of Odense (H.C. Andersen Children´s Hospital)

    Odense

Other trials in Denmark

About this study

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
Read more

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.
  1. 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

Read the 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)
  1. 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

Being tested
chemotherapy
Keywords
NEUROBLASTOMA, LOW RISK, INTERMEDIATE RISK
Medical subject headings
Neuroblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chemotherapyDrug

Study groups in NCT01728155
Study groupRoleWhat they receive
Group1No interventioninitial observation (chemotherapy is only given if there is subsequent progression)
Group 1: chemotherapyActive comparatorchemotherapy and surgery
Receives: Drug: chemotherapy
Group 2Experimentalchemotherapy and surgery
Receives: Drug: chemotherapy
Group 3Experimentalchemotherapy and surgery
Receives: Drug: chemotherapy
Group 4No interventionObservation
Group 5Experimentalchemotherapy
Receives: Drug: chemotherapy
Group 6Experimentalchemotherapy and surgery
Receives: Drug: chemotherapy
Group 7Experimentalchemotherapy and surgery
Receives: Drug: chemotherapy
Group 8Experimentalchemotherapy, surgery, radiotherapy and 13 cis-retinoic acid
Receives: Drug: chemotherapy
Group 9Experimentalchemotherapy, surgery, radiotherapy and 13 cis-retinoic acid
Receives: Drug: chemotherapy
Group 10Experimentalchemotherapy, surgery,
Receives: Drug: chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%.

    Measured: 2 years

  2. 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).

    Measured: 2 years

  3. 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.

    Measured: 3 year

Secondary outcomes (17)

  1. 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)

    Measured: 2 year

  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)

    Measured: 2 year

  3. 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)

    Measured: 2 year

  4. To evaluate adherence to the protocol recommendations regarding LTS

    Measured: 5 years

  5. To reduce surgical morbidity by promoting strict adherence to Image Defined-Risk Factors (IDRFs) to determine surgical resectability

    Measured: 5 year

  6. 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).

    Measured: 5 year

  7. 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).

    Measured: 3 year

  8. 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)

    Measured: 3 year

  9. 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).

    Measured: 3 year

  10. 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).

    Measured: 5 years

  11. To manage infants with suprarenal masses discovered ante or neonatally with a uniform approach in Europe in a multicentre setting.

    Measured: 5 years

  12. 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.

    Measured: 3 years

  13. To determine the 3-year surgery-free survival in infants with suprarenal masses discovered ante or neonatally and managed conservatively (non initial surgery).

    Measured: 3 years

  14. To find out the natural history of perinatal suprarenal masses, according to the definitions set up for the study.

    Measured: 5 years

  15. 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).

    Measured: 5 years

  16. To collect tissue from those suprarenal masses excised in order to perform standard and investigational pathological and biological studies (INPC, MYCN, 1p, 11).

    Measured: 5 years

  17. To collect frozen plasma from all patients included in the study in order to perform research.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2012 (estimated)
  2. Study start1 Jan 2011
  3. Primary completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
685 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01728155
Sponsor's protocol ID
LINES
Status last verified
Aug 2023
First submitted
13 Nov 2012
Last updated
8 Sep 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 8336186

  • 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.

    PubMed 19047291

  • 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.

    PubMed 19171711

  • 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.

    PubMed 19171713

  • 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.

    PubMed 17579628

  • 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.

    PubMed 16293878

  • 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.

    PubMed 19047290

  • 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.

    PubMed 18766186

  • 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.

    PubMed 19047282

  • 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.

    PubMed 19171715

  • 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.

    PubMed 18349403

  • 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.

    PubMed 9649151

  • Castel V, Badal MD, Bezanilla JL, Llombart A, Ruiz-Jimenez JI, Sanchez de Toledo J, Melero C, Mulet J. Treatment of stage III neuroblastoma with emphasis on intensive induction chemotherapy: a report from the Neuroblastoma Group of the Spanish Society of Pediatric Oncology. Med Pediatr Oncol. 1995 Jan;24(1):29-35. doi: 10.1002/mpo.2950240107.

    PubMed 7968789

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing chemotherapy in people with LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES, run by Instituto de Investigacion Sanitaria La Fe at 98 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in Italy, Spain, Switzerland, Belgium, Sweden and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary aim for Low Risk Neuroblastoma (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01728155, which also lists 112 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.

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