SIOPEN Low and Intermediate Risk Neuroblastoma European Study (LINES)
Chief Investigator: Dr Adela Cañete
Sponsor: Instituto de Investigacion Sanitaria La Fe, Valencia
Funders: different funders between countries
Low Risk Neuroblastoma European Study (LINES)
European Low and Intermediate Risk Neuroblastoma (LINES, EudraCT: 2010-021396-81, ClinicalTrials.gov Identifier: NCT01728155) is an international SIOPEN clinical trial sponsored by IIsLaFE (Spain).
In July 2011, the LINES trial obtained approval from the Spanish National Competent Authority and the Ethic Committees. Since then, the trial has been opened in Austria, Australia, Belgium, Denmark, France, Ireland, Israel, Italy, New Zealand, Norway, Portugal, Sweden and Switzerland.
Treatment of patients with “non-high-risk” NB is grouped into a single protocol, with nine different therapeutic groups and one randomised group. Additionally, neonatal suprarenal masses are included. All the cases are registered at SIOPEN-R-NET with check-points to control the quality of prospectively entered staging data and there is real time central review for biology and histology.
Aims
This study aims to improve the outcome for patients with newly diagnosed low and intermediate -risk neuroblastoma.
LINES stratifies NB patient’s treatment according to biological and clinical markers in order to:
Minimize the treatment burden in those low-risk patients who in previous studies were shown to have an excellent long-term outcome
Intensify treatment in those patients with biologically unfavorable (but not MYCN amplified) neuroblastoma to improve outcomes.
Further details about the trial can be found at clinicaltrials.gov database: https://clinicaltrials.gov/ct2/show/NCT01728155
Funders
SPONSOR and for Spain: The research leading to these results has received funding from the European Union’s Seventh Framework Programme (FP7/2007–2013) under the project ENCCA, grant agreement n◦261474. Asociacion Pablo Ugarte (APU) (www.asociacionpablougarte.es).
For Austria: St. Anna Children’s Cancer Research Institute (CCRI), (https://ccri.at/)
For Australia: Children’s Cancer Foundation (https://www.childrenscancerfoundation.com.au/).
For Greece: Floga – Parents’ Association of Children with Cancer (www.floga.org.gr/en/floga/).
For Ireland: HRB - Health Research Board (https://www.hrb.ie/).
For Italy: Fondazione Italiana per la Lotta al Neuroblastoma, Genova in Italy (https://neuroblastoma.org/).
For France: For NAM: the Association Hubert Gouin–Enfance et Cancer, the Fédération Enfant & Santé and the French Society of Pediatric Oncology in France
For IR: La Société Française de lutte contre les Cancers et les leucémies de l’Enfant et de l’adolescent (SFCE) (https://sf-cancers-enfant.com/); Gifts and Legacies department (Centre Oscar Lambret) https://www.centreoscarlambret.fr/.
For Portugal: Fundação Rui Osório de Castro.
For Sweden: Swedish Childhood Cancer Foundation (http://2016.barncancerfonden.se/en/bcf_om.html)
