A Prospective Randomised Controlled Trial of Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma
Patients eligible for the study will be those with non-metastatic medulloblastoma (by
imaging and CSF cytology) at diagnosis. Patients randomised to the standard arm will receive
conventionally fractionated (once a day) radiotherapy with a dose of 54 Gy to the posterior
fossa and 23.4 Gy to the craniospinal axis. The experimental arm will be hyperfractionated
(twice a day) radiotherapy (1 Gy b.d.) with a dose of 60 Gy to the posterior fossa with an
additional 8 Gy to the tumour bed and 36 Gy to the craniospinal axis. Both groups will
receive identical chemotherapy consisting of eight weekly doses of Vincristine given with
radiotherapy and 8 courses of CCNU, cisplatin and vincristine following radiotherapy.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Free survival rate
To compare in a randomised trial the event free survival rate for children and adolescents with standard risk medulloblastoma treated with either hyperfractionated radiotherapy or reduced dose radiotherapy with conventional fractionation.
2 years after the start of the study
DOZ François, MD
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)