EORTC 1634-BTG/NOA-23 (Sonidegib)
Personalized Risk- Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma (PersoMed-I)
Recruiting
Summary
| The Phase II Trial investigates a personalized treatment, based on age and tumor characteristics , of newly diagnosed medullablastoma in patients that are postpubertal and/or adult consisting of lowering RT, chemotherapy doses and adding the investigative drug sonidegib, a selective SHH inhibitor. In the Sonic Hedgehog (SHH)-dependent subgroup, the personalized intensity-modulated therapy (experimental arm; sonidegib) is compared to standard therapy (modified NOA-07). |
Main inclusion criteria
- Newly diagnosed, histologically proven, genetically classified, centrally confirmed medulloblastoma (molecular subtype: SHH-activated and TP53-wildtype, WNT-activated, medulloblastoma Group 4)
- post-pubertal patients (< 18 years with rad. confirmed bone age of at least 15 y. for girls/17 y. for boys) or adults 18 years and older with SHH-activated and TP53 wild-type medulloblastoma
Sponsor
European Organisation for Research and Treatment of Cancer (EORTC)