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PAge69
1/25/2016 |
Author
Division
a
Olaf Witt
SIOP LGG 201X
Strategisches Konzept
Trial design
MEKi
under discussion:
•
Introduce MEKi now
•
skip 12 vs 18 months randomization
•
keep adaptive design
2
2
Primary objectives:
=> PFS & CNS & visual function
=> biomarker driven prediction of
overall course of disease
Secondary objectives:
=> PA, DG2, infants, other LGGs
=> outcome in molecular subgroups
=> neuro-psychology, endocrinology,
diencephalic syndrome,
neurotox+pharmacogenomics