Non High-Risk Neuroblastoma European Strategy: SIOPEN LINES Protocol Implementation, Challenges, and Achievements. Conference, Cologne, Germany, 13-16 May, 2014, POC 47 pag.246.

Background: The Low and Intermediate Risk Neuroblastoma SIOPEN study (LINES), opened in 2011, stratifies patient’s treatment according to biological and clinical markers in order to: i) minimize the treatment burden in those low-risk patients who in previous studies were shown to have an excellent long-term outcome, ii) intensify treatment in those patients with biologically unfavourable but not MYCN amplified neuroblastoma to improve outcome. Methods: LINES (EudraCT: 2010-021396-81, ClinicalTrials.gov Identifier: NCT01728155) includes ten separate therapeutic groups, one of them randomised. After the trial has opened in a SIOPEN country following the National and European legislation, patient data is entered into the Siopen-r-net database following registration of the patient with check-points to control the quality of prospectively entered staging data, including real time central review for biology and histology. Neonatal adrenal masses (NAM) in infants below 3months are also registered. Results: In July 2011, the LINES trial with an international sponsor of IIsLaFE (Spain) obtained approval from the Spanish Competent Authority and Ethic Committees and opened at 28 Spanish sites. Since then the trial has been opened in Italy (21 sites), Austria (5 sites), Denmark (3 sites), France (29 sites), Norway (4 sites), Israel (1 site) and Belgium (4 sites). Since December 2011, 100 patients have been enrolled. Distribution according to groups is as follows: 52 low risk, 24 intermediate risk and 24 NAM. Conclusion: 1/ Recruitment is rapidly increasing in countries where the trial has been opened. 2/ Quality control check-points are functioning in a timely manner. 3/ It has become evident that it is essential to review the current European directive to facilitate prompt and fast new trial implementation across all European countries