Elderly glioblastoma
Conditions
Interventions
temozolomide therapy for methylated MGMT cases, radiation therapy for unmethylated MGMT cases
Sponsors
Saitama Medical University International Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histopathologically confirmed newly diagnosed glioblastoma multiforme (GBM, WHO grade 4). The histological diagnosis must have been made after biopsy or neurosurgical tumour resection 2) Initial surgery/biopsy at diagnosis performed within 4 weeks (28 days) prior to registration. 3) 70 years or older 4) Karnofsky performance status 60 or higher 5) Patient has not received prior chemotherapy or radiotherapy. 6) Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 14 days prior to registration Absolute granulocyte count above 1.5 x 109/L Platelet count above 100x109/L ALT (GPT) 100 IU/L or under AST (GOT) 100 IU/L or under Total serum bilirubin 1.5 mg/dL or under Serum creatinine 1.5 mg/dL or under 7) Written informed consent 8) Protocol treatment is to begin within 3 weeks of MGMT status determination.
Exclusion criteria
Exclusion criteria: 1) Previous or concurrent cancer within 5 years, excluding carcinoma in situ, skin cancers except melanoma which was curatively treated 2) Infectious disease requiring systemic treatment 3) Psychotic disorder 4) hepatitis B virus carrier
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, Response Rate, Toxicity, QOL | — |
Countries
Japan
Contacts
Public ContactMitsuaki Shirahata
Saitama Medical University International Medical Center Department of Neuro-Oncology
Outcome results
None listed