With the collaboration of 3 major medical institutions in Germany, Italy and France, this European partnership has combined forces to create the largest clinical trial for PLGA children ever. Set to open in the second half of 2015, the trial is expected to enroll 3000 patients from 19 different European countries over the course of 5 years.
The focus of this trial, titled “Prospective assessment of predictive/prognostic molecular biomarkers in the SIOP-LGG 201X adaptive phase III clinical trial cohort” is to identify the optimum treatment regimen with respect to efficacy, improvement of visual and neurological function, reduction of neurotoxicity as well as treatment duration using a randomized comparison of vinblastine (VBL) versus vincristine (VCR) in a carboplatin-based chemotherapy regimen.
An additional novel point of the planned trial is the adaptive design and interim analyses (from year 3 onward), which will allow for the timely investigation of novel targeted agents, once a chemotherapy standard of care ‘winner’ has been established. This trial will establish new precedents for treating children with these two ‘gold standard’ treatments and make room for comparative studies as new targeted drug therapies are developed.
A Kids’ Brain Tumor Cure Foundation is a proud sponsor of this unprecedented clinical trial.