glioblastoma, high-grade glioma
Conditions
Interventions
combination therapy with temozolomide and bevacizumab
Sponsors
Department of Neurosurgery, Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histological or imaging diagnosis of high-grade glioma 2) Age more than 75 3) PS (ECOG): 0, 1, 2. PS3 by neurological deficit caused by the brain tumor is also accepted. 4) Laboratory criteria (within 2wks before registration) Neutro more than 1,500/mm3 Hb more than 8.0 g/dL Plt more than 100,000/mm3 AST (GOT) less than 3 folds of upper limit ALT (GPT) less than 3 folds of upper limit total bilirubin less than 2.0 mg/dL serum creatinine less than 1.5 mg/dL
Exclusion criteria
Exclusion criteria: 1) presence of active infection that needs systemic treatment 2) history of cranial irradiation 3) hemorrhagic diathesis, coagulation disorder (anticoagulant/antiplatelet drugs are permitted) 4) serious cardiac disorder 5) history of myocardial infarction, cerebral infarction, deep vein thrombosis, or pulmonary embolism within 6 months 6) history of symptomatic intracranial hemorrhage within 6 months 7) uncured wound 8) poor control hypertension 9) serious, active peptic ulcer 10) pulmonary fibrosis or interstitial pneumonia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, progression-free survival | — |
Countries
Japan
Contacts
Public ContactYuko Tatsuno
Keio University School of Medicine Neurosurgery
Outcome results
None listed