Temozolomide as monotherapy for elderly and temozolomide sensitive glioblastoma
- Conditions
- glioblastoma
- Registration Number
- JPRN-jRCTs031200438
- Lead Sponsor
- Tateishi Kensuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 5
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method