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An Van Damme – Belgian Society for Pediatric Hematology and Oncology: LOGGIC Europe: Phase III, randomised, international multicentre trial for children and adolescents with low-grade glioma

Beschrijving

2018 - Low grade glioma is a group of brain tumours that are classically determined to be biologically benign. They are associated with a high 10-year overall survival of 94%. However, the natural behaviour of these tumours, due to its localisation in important brain structures is not always benign. Since these tumors are often not amenable to surgical resection, more than one in three patients needs drug treatment for non-resectable, clinically symptomatic and/or radiologically progressive disease. With current treatment strategies, the 10 years progression free survival (PFS) rate is 45%. Losses of visual acuity, neurologic, cognitive, emotional, and endocrinological function are clinically significant acute and long-term morbidities. Several treatment options are currently used to treat these patients but they have never been directly compared to each other in terms of efficacy and toxicity profile. Recently, it has been recognized that activating alterations within the MAPK-pathway are the underlying cause of all pilocytic astrocytomas. Several MEK-inhibitors (MEKi) are currently in development for use in children. These drugs specifically target this underlying pathogenic pathway. The aim of this trial is to identify the optimum treatment regimen with respect to efficacy, improvement of neurological and visual function, randomising vincristine and carboplatin versus vinblastine versus trametinib (MEKi). The LOGGIC Trial for the first time prospectively measures visual acuity and adaptive behaviour as primary outcomes after non-surgical treatment. A molecular biomarker program will define the underlying molecular alterations to prospectively determine novel biomarkers for treatment response prediction and risk stratification.

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