Glioblastoma Glioblastoma, Brain tumor
Conditions
Interventions
Tumor treating field therapy using NovoTTF-100A for 28 days as a course, repeating up to 26 courses.
NovoTTF-100A, Tumor treating field therapy
Sponsors
Yuza Yuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histopathological diagnosis with glioblastoma 2. Main disease located in the supratentorial region 3. Aged between 5 and 17 4. Newly diagnosed or first recurrence 5. After completion of clinically indicated surgical resection of the tumor 6. After completion of clinically indicated radiation therapy, or due of the completion is within 14 days 7. Karnofsky/Lansky performance status (PS) equals to or more than 70 8. Written informed consent from the patient and/or the guardian
Exclusion criteria
Exclusion criteria: 1. Life expectancy less than 3 months due to disease progression 2. Uncontrollable infection or organ damage 3. More than 100 days after diagnosis (or diagnosis of the recurrence in a recurrent case) 4. Treated with implantable medical devices 5. Other experimental treatment for glioblastoma 6. Pregnancy or possibility of pregnancy 7. Other reasons with which the responsible doctor judge that registration to the trial is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of adverse events with causality | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response rate 2. Clinical benefit rate 3. Event-free survival rate (6 months and 1 year) 4. Overall survival rate (1 and 2 years) 5. Event-free survival 6. Overall survival 7. QOL (PedsQL Core scale & Brain tumor module) 8. rate of adverse events | — |
Contacts
Public ContactAtsushi Makimoto
Tokyo Metropolitan Children's Medical Center
Outcome results
None listed