Irinotecan, Vincristine, Etoposide, Carboplatin, and Cyclophosphamide for Refractory or Relapsed Brain Tumor in Children and Adolescents
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate response rate (more than stable disease) of combination chemotherapy
- Response Criteria : WHO-based "Macdonald criteria", based on MRI Complete Response : disappearance of all enhancing tumor Partial Remission : more than 50 percentage decrease in the tumor measurement compared with the baseline scan Stable Disease : includes changes that do not meet criteria for CR, PR, or progressive disease (PD) Progressive Disease : more than 25 percentage increase in tumor measurement compared with the lesion size that defines the nadir, or smallest measurement, in the serial studies
every 3 months
No
Hyoung Jin Kang, M.D., ph.D
Principal Investigator
Seoul National University Hospital
Korea: Food and Drug Administration
SNUCH-1201
NCT01535183
January 2012
December 2016
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