Pediatric ependymoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Tumor removal or biopsy performed as an initial treatment, and diagnosed ependymoma by central review for pathological diagnosis according to the protocol 2) Within 6 weeks after tumor removal or biopsy 3) No dissemination other than initial tumor location 4) Age, no less than 3 years-old and under 20 years-old when they are included to this clinical trial 5) Without any previous radiation therap y and chemotherapy 6) ECOG Performance Status(PS) with no more than 3 7) Written informed consent on this clinical trial For no less than 16 years-old, Informed consent with patient and his or her alternatives For no more than 15 years-old, Informed consent with patient's alternatives
Exclusion criteria
Exclusion criteria: 1)Synchronous or an asynchronous(within 5 years) other cancer 2)Existing heart disease to be treated 3)Pregnant or during breast-feeding 4)Inappropriate inclusion judged by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 Year - Progression Free Survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 Year - Progression Free Survival rate for each Group, WHO classification 2 Year - Overall Survival rate 5 Year - Progression Free Survival rate 5 Year - Overall Survival rate 7 Year - Progression Free Survival rate 7 Year - Overall Survival rate Re-operation rate after completion of chemotherapy Extent of surgical removal rate Response rate of chemotherapy Occurrence rate of adverse events (for al l cases, and for each Group) Relationship between molecular diagnosis and clinical characteristics Relationship between clinical characteristics and therapies and neuropsychological function | — |
Countries
Japan
Contacts
University of Tsukuba, Faculty of Medicine Neurosurgery