Malignant brain tumor
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) 20 years old or older 2) Histologically diagnosed as malignant brain tumor 3) Intractable patients who do not respond to standardized therapy or high-risk patients who cannot undergo standardized therapy 4) Expected survival longer than 2 months 5) Informed consent obtained from the patients themselves
Exclusion criteria
Exclusion criteria: 1) Infected patients 2) Malnutrition 3) Severe comorbid such as heart disorders, colon dysfunction, lung fibrosis, uncontrolled diabetes mellitus, and chronic renal failure 4) Psychological disorders 5) Pregnancy 6) Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Outcome Clinical outcome is assessed using RECIST (Response Evaluation Criteria in Solid Tumors) on MRI and is categorized into complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD). 2) Incidence of the following adverse events a) General condition Fatigue, fever, headache, hypotension, bradycardia, respiratory distress, allergic reaction b) Local condition Local pain, dermatitis, skin necrosis c) Laboratory examinations RBC, Hb, WBC, platelet, ALT (GOT), AST (GPT), LDH, T-bil, Cr d) Others | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Karnofsky performance status (KPS) 2) Pre- and post-treatment radiological findings a) MRI b) MRS c) 201Tl SPECT d) 16F-FDG PET | — |
Countries
Japan
Contacts
Toyama University Hospital Neurosurgery