European Low and Intermediate Risk Neuroblastoma Protocol

NCT01728155 | Completed Phase 3 DMC

• 1 other identifier: LINES
• Study Type: interventional
• Target: 685
• Locations: 9 countries
• Sites: 95

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

Conditions

LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES

Keywords

NEUROBLASTOMA, LOW RISK, INTERMEDIATE RISK

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (17)

• 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

Study Arms (11)

Group1

NO INTERVENTION

initial observation (chemotherapy is only given if there is subsequent progression)

Group 1: chemotherapy

ACTIVE COMPARATOR

chemotherapy and surgery

Drug: chemotherapy

Group 2

EXPERIMENTAL

chemotherapy and surgery

Drug: chemotherapy

Group 3

EXPERIMENTAL

chemotherapy and surgery

Drug: chemotherapy

Group 4

NO INTERVENTION

Observation

Group 5

EXPERIMENTAL

chemotherapy

Drug: chemotherapy

Group 6

EXPERIMENTAL

chemotherapy and surgery

Drug: chemotherapy

Group 7

EXPERIMENTAL

chemotherapy and surgery

Drug: chemotherapy

Group 8

EXPERIMENTAL

chemotherapy, surgery, radiotherapy and 13 cis-retinoic acid

Drug: chemotherapy

Group 9

EXPERIMENTAL

chemotherapy, surgery, radiotherapy and 13 cis-retinoic acid

Drug: chemotherapy

Group 10

EXPERIMENTAL

chemotherapy, surgery,

Drug: chemotherapy

Interventions

chemotherapy DRUG

Group 10; Group 1: chemotherapy; Group 2; Group 3; Group 5; Group 6; Group 7; Group 8; Group 9

Eligibility Criteria

• Age: 90 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \* Diagnosis of ganglioneuroma or ganglioneuroblastoma intermixed INRG Stage L2
• \*age ≤ 18 months
• any metastatic site
• MYCN amplification
• age \> 18 months INRG Stage Ms
• \* age ≤ 12 months
• bone, pleura/lung and/or CNS metastasis
• MYCN amplification
• age \> 12 months
• INTERMEDIATE RISK STUDY
• 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)
• \* Diagnosis of ganglioneuroma or ganglioneuroblastoma intermixed
• INRG Stage L1 and INSS stage 1:

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (98)

Monash Children's Hospital

Clayton, Australia

Location

Perth Children's Hospital

Nedlands, Australia

Location

Sydney Children's Hospital

Sydney, Australia

Location

PHO Med Uni Graz

Graz, Austria

Location

Department Kinder- und Jugendheilkunde

Innsbruck, Austria

Location

Landes-Frauen- und Kinderklinik Linz

Linz, Austria

Location

St. Anna Kinderspital

Vienna, Austria

Location

Univ Klinik für Kinder- und Jugendheilkunde

Vienna, Austria

Location

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

Antwerp, Belgium

Location

Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)

Brussels, Belgium

Location

UCL Clíniques Universitaires Saint - Luc

Brussels, Belgium

Location

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

Universitair Ziekenhuis Leuven

Leuven, Belgium

Location

CHC- Clinique de l'Espérance à Liège

Liège, Belgium

Location

CHR de la Citadelle

Liège, Belgium

Location

Aarhus University Hospital

Aarhus, Denmark

Location

National State Hospital (Department of Pediatrics)

Copenhagen, Denmark

Location

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

Odense, Denmark

Location

Soroka Medical Center

Beersheba, Israel

Location

Rambam Health Care Campus

Haifa, Israel

Location

Schneider Children's Medical Center

Petah Tikva, Israel

Location

Ichilov Hospital Sourasky Medical Center

Tel Aviv, Israel

Location

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

Ancona, Italy

Location

Azienda Ospedaliera - Universitaria Ospedale Policlinico Consorziale

Bari, Italy

Location

Azienda Ospedaliera Ospedali Riuniti di Bergamo

Bergamo, Italy

Location

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

Bologna, Italy

Location

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

Location

Ospedale Microcitemico

Cagliari, Italy

Location

Oncology Policlinico- Department of Hematology

Catania, Italy

Location

Azienda Ospedaliero-Universitaria di Ferrara- Oncoematologia Pediatrica

Ferrara, Italy

Location

Azienda Ospedaliero-Universitaria Ospedale Pediatrico Meyer

Florence, Italy

Location

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

Genova, Italy

Location

Istituto Nazionale dei Tumori di Milano- Onco-ematologia Pediatrica

Milan, Italy

Location

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

Modena, Italy

Location

Azienda Ospedaliera Pediatrica Santobono Pausilipon

Napoli, Italy

Location

Sec. Università degli studi di Napoli - Policlinico

Napoli, Italy

Location

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

Padua, Italy

Location

Ospedale dei Bambini G. Di Cristina

Palermo, Italy

Location

Azienda Ospedaliero - Universitaria di Parma- Oncoematologia Pediatrica

Parma, Italy

Location

Fondazione IRCCS - Policlinico San Matteo - Oncoematologia Pediadrica

Pavia, Italy

Location

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

Pescara, Italy

Location

Ospedale Infermi di Rimini - U.O. Pediatria

Rimini, Italy

Location

Ospedale Pediatrico Bambino Gesù- Oncoematologia pediatrica

Roma, Italy

Location

Ospedale Policlinico Universitario Agostino Gemelli

Roma, Italy

Location

Policlinico Umberto I

Roma, Italy

Location

Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

Azienda Ospedaliera Universitaria Senese - Clinica Pediatrica

Siena, Italy

Location

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

Torino, Italy

Location

Ospedale Cardinale G. Panico

Tricase, Italy

Location

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

Trieste, Italy

Location

Policlinico G.B. Rossi- Oncoematologia Pediatrica

Verona, Italy

Location

Haukeland University Hospital

Bergen, Norway

Location

Oslo University Hospital, Rikshospitalet. (National coordinator)

Oslo, Norway

Location

University Hospital of Northern Norway

Tromsø, Norway

Location

St Olavs University Hospital

Trondheim, Norway

Location

Hospital de Sabadell

Sabadell, Barcelona, Spain

Location

Hospital Universitario Montepríncipe

Boadilla del Monte, Madrid, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Location

Hospital General Universitario de Albacete

Albacete, Spain

Location

Hospital General Universitario de Alicante

Alicante, Spain

Location

Complejo Hospitalario Torrecárdenas

Almería, Spain

Location

Hospital Infanta Cristina

Badajoz, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Materno Infantil Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario Cruces

Bilbao, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital Universitario Materno Infantil Virgen de las Nieves

Granada, Spain

Location

Hospital Materno Infantil de Jaén

Jaén, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Infantil la Paz

Madrid, Spain

Location

Hospital Universitario Infantil Niño Jesús

Madrid, Spain

Location

Hospital Regional Universitario Carlos Haya - Hospital Materno Infantil

Málaga, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Hospital Virgen del Camino

Pamplona, Spain

Location

Hospital Universitario Donostia

San Sebastián, Spain

Location

Hospital Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Instituto de Investigacion Sanitaria La Fe

Valencia, 46009, Spain

Location

Hospital Clínic Universitari

Valencia, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

Queen Silvia's Children's Hospital

Gothenburg, Sweden

Location

Linköping University Hospital

Linköping, Sweden

Location

Skåne University Hospital

Lund, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Norrlands University Hospital

Umeå, Sweden

Location

Uppsala Academic Children's Hospital

Uppsala, Sweden

Location

Kantonsspital Aarau

Aarau, Switzerland

Location

Universitäts-Kinderspital beider Basel

Basel, Switzerland

Location

Ospedale San Giovanni

Bellinzona, Switzerland

Location

Inselspital Bern

Bern, Switzerland

Location

HUG Hôpitaux Universitaires Genève

Geneva, Switzerland

Location

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

Lausanne, Switzerland

Location

Luzerner Kantonsspital

Lucerne, Switzerland

Location

Ostschweizer Kinderspital

Sankt Gallen, Switzerland

Location

Universitäts-Kinderspital Zürich

Zurich, Switzerland

Location

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Related 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

MeSH Terms

Conditions

Neuroblastoma

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 16, 2012
• Study Start: January 1, 2011
• Primary Completion: December 31, 2022
• Last Updated: September 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (6); BE (8); IL (4); CH (9); AU (5); IT (29); DK (3); NO (4); ES (27)