Glioblastoma
Conditions
Interventions
A: Initial therapy: temozolomide (75mg/m2/day, administered orally everyday from the first day to the last day of radiotherapy) with radiotherapy (60 Gy/30 fr, 5 days/week) Maintenance therapy:
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven glioblastoma 2) Supratentorial tumor on preoperative MRI. 3) No tumor recognized in the optic nerve, olfactory nerve and pituitary gland on preoperative MRI. 4) No multiple legions or dissemination recognized on preoperative MRI 5) Planning target volume (irradiated 60Gy) is less than 1/3 of the brain volume 6) Three to 20 days after surgery for glioblastoma (removal or biopsy) 7) Aged 20 to 75 years old 8) ECOG performance status of 0,1 or 3 due to neurological signs caused by the tumor 9) No prior chemotherapy or radiation therapy for any malignant diseases 10) Sufficient organ functions 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Simultaneous or metachronous (within the past 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 2) Infection with systemic therapy indicated 3) fever over 38 degrees Celsius 4) Active infectious meningitis 5) Women during pregnancy, possible pregnancy or breast-feeding 6) Psychosis 7) Uncontrollable diabetes mellitus or administration of insulin 8) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months 9) Interstitial pneumonia, or fibroid lung 10) Patients who can 't receive gadolinium
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, complete response rate, response rate, adverse events | — |
Countries
Japan
Contacts
Public ContactAtsushi Natsume
JCOG0911 Coordinating Office Department of Neurosurgery, Nagoya University School of Medicine
Outcome results
None listed