Prospective, open label, multicentre, international umbrella study including a randomised phase III trial on the non-inferiority of 3 courses of high-dose chemotherapy compared with focal radiotherapy plus standard chemotherapy in consolidation after conventional induction chemotherapy for children with ATRT aged 12 - 35 months at the time of radiotherapy.
Randomised arm Part A
To test the non-inferiority, measured by 2-year overall survival, of 3 courses of high-dose chemotherapy (HDCT) compared with focal radiotherapy plus conventional chemotherapy in consolidation after conventional induction chemotherapy for children with ATRT who are 12 - 35 months old at the time of consolidation.
Part B (non-randomised)
To evaluate the effectiveness, measured by overall survival, of 3 courses of high-dose chemotherapy as a consolidation measure after conventional chemotherapy for induction in children with ATRT who are younger than 12 months at the time of HDCT or who have contraindications to radiotherapy and do not qualify for Part A. Patients are compared with historical controls.
Part C (non-randomised)
Evaluation of the effectiveness, measured by overall survival, of radiotherapy as a consolidation measure, combined with up to 12 courses of conventional chemotherapy in children =36 months of age or those who have a contraindication to high-dose chemotherapy and do not qualify for Part A of this study. The historical control group serves as a comparison.
Prospective, open label, multicentre, international umbrella study including a randomised phase III trial on the non-inferiority of 3 courses of high-dose chemotherapy compared with focal radiotherapy plus standard chemotherapy in consolidation after conventional induction chemotherapy for children with ATRT aged 12 - 35 months at the time of radiotherapy.
