SIOPEL 6, A Multicentre Open Label Randomised Phase III Trial of the Efficacy of Sodium Thiosulphate in Reducing Ototoxicity in Patients Receiving Cisplatin Chemotherapy for Standard Risk Hepatoblastoma.
SIOPEL 6 is being conducted by The International Childhood Liver Tumour Strategy Group, SIOPEL, a group of medical specialists founded in 1987 under the umbrella of the International Society of Paediatric Oncology (SIOP). The study was initiated in October 2007 and completed enrollment of 109 evaluable patients in 45 sites from 12 countries in December 2014.
The SIOPEL trial is being conducted in standard risk hepatoblastoma where the effectiveness of the platinum treatment is very high, and the trial is being carefully monitored to identify an excess treatment failure rate.
Interim two year results of clinical efficacy of cisplatin in combination with sodium thiosulfate (STS) vs cisplatin alone were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. The data presented are described under the STS Product Candidate page and in the corporate presentation.