glioblastoma
Conditions
Interventions
Place polifeprosan 20 with carmustine implant on the tumor cavity during the operation. Initial therapy(temozolomide+IFN beta+radiation ) starts within 21 days after the operation. Maintenance thera
Sponsors
Department of Neurosurgery,Nagoya University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)suspicion of 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)Aged 20 to 75 years old 7)ECOG performance status of 0,1 or 3 due to neurological signs caused by the tumor 8)No prior chemotherapy or radiation therapy for any malignant diseases 9)Sufficient organ functions 10)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 11)drug contraindication to use (carmustine, interferon beta, of temozolomide).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival progression free survival response rate adverse event | — |
Countries
Japan
Outcome results
None listed