newly diagnosed glioblastoma
Conditions
Interventions
vaccine
non vaccine
Sponsors
Tokyo Women's Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 16 to 75 years of age. 2) Newly diagnosed and histologically confirmed glioblastoma (WHO grade IV) in supratentrial brain without dissemination. 3) Maximum surgical resection was performed. 4) Enough mass of tumor reserved as fixed specimen. 5) Karnofsky performance scale is equal to or more than 60 %, and life expectancy expected at least 3months. 6) Standard radiotherapy in 60 Gy will be performed. 7) Patient informed his/her diagnosis, and has enough ability to comprehend and consent to the study. 8) Vaccination and follow-up will perform under the institutions.
Exclusion criteria
Exclusion criteria: 1) Patients who have been administered or are taking corticosteroid. 2) Patients who implantated of carmustine wafers in the surgical cavity. 3) Patients with high intracranical pressure. 4) Patients with severe myelosupression. 5) Patients with severe complication including hematopathy 6) Patients with malignant tumor or cancer except malignant glioma. 7) Pregnant or nursing woman, or woman willing to be pregnant. 8) Patients participate in other study during or within 6 months before temozolomide administration in this study. 9) Patients who has HBV or HCV. 10) Other reasons for exclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Cause-specific survival 2) Progression-free survival 3) Tumor-regression rate, disease-control rate 4) QOL 5) Neurological improvement | — |
Countries
Japan
Contacts
Public ContactTakashi Maruyama
Tokyo Women's Medical University Dep. of Neurosurgery, Neurological Institute
Outcome results
None listed