glioblastoma
Conditions
Interventions
Temozolomide 5days on/23 days off. maximum 12 cycles.
Sponsors
Tateishi Kensuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed histologically and genetically confirmed glioblastoma. 2. Registration should be completed by 28 days after surgery. 3. MGMT methylated. 4. Drug sensitivity assay indicating temozolomide sensitive. 5. More than 71 years old and KPS 50. 6. Adequate organ function indicated by all of the following. 1)neutrophil count more than 1,500/mm3 2)Platelet count more than100 thousands 3)AST, ALT less than 100IU/L 4)Total bilirubin less than 1.5mg/dL 5).Serum creatinine less than 1.5mg/dL 7. Regardless of the presence of mesurable lesions. 8. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Active infection, or critical status for treatment. 2. Multiple primary cancers with disease-free period less than 5 years, except carcinoma in situ or intra mucosal disease cured by local therapy. 3. Known hypersensitivity to temozolomide. 4. Patients with active hepatic disease. 5. Carmustine wafer (Gliadel). 6. Any prior chemotherapy, radiotherapy. 7. Attending physician has determined unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival, overall response rate, aadverse events, QOL, cognitive function | — |
Contacts
Public ContactKensuke Tateishi
Yokohama City University
Outcome results
None listed