Newly diagnosed with an intracranial or spinal ependymoma (all WHO grades) including ependymoma variants: cellular, papillary, myxopapillary, clear-cell and tanycytic or anaplastic ependymoma.
Conditions
Brief summary
Overall program : Gross Total Resection (GTR) rate, Stratum 1 and 3 : Progression Free Survival (PFS), Stratum 2 : Number of treatment responders (according to central radiological review)
Detailed description
Overall program : Second look surgery rate, All interventional strata : Efficacy in each molecular sub-group in terms of PFS and OS, All interventional strata : Overall Survival, All interventional strata : Neuroendocrine outcomes, All interventional strata : Neuropsychological outcomes, All interventional strata : Quality of Survival, All interventional strata : Adverse events (CTCAE v4.03), Stratum 2 : Proportion of patients in whom the result of the central radiological review confirms the local review., Stratum 2 : Progression Free Survival, Stratum 3 : Radiotherapy-free survival rate
Interventions
DRUGCisplatin 1 mg/ml Concentrate for Solution for Infusion
DRUGVincristine sulphate
DRUGsolution for injection 1 mg/ml
DRUGEpilim Syrup 200 mg/5 ml
DRUGMethotrexate 100 mg/ml Injection
DRUGCyclophosphamide 2000 mg Powder for Solution for Injection or Infusion
Sponsors
Centre Leon Berard
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall program : Gross Total Resection (GTR) rate, Stratum 1 and 3 : Progression Free Survival (PFS), Stratum 2 : Number of treatment responders (according to central radiological review) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall program : Second look surgery rate, All interventional strata : Efficacy in each molecular sub-group in terms of PFS and OS, All interventional strata : Overall Survival, All interventional strata : Neuroendocrine outcomes, All interventional strata : Neuropsychological outcomes, All interventional strata : Quality of Survival, All interventional strata : Adverse events (CTCAE v4.03), Stratum 2 : Proportion of patients in whom the result of the central radiological review confirms the local review., Stratum 2 : Progression Free Survival, Stratum 3 : Radiotherapy-free survival rate | — |
Countries
Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Spain
Outcome results
None listed