Phase I/IIa clinical trial of Boron neutron Capture Therapy for the patients with recurrent malignant brain tumor
Phase 1
- Conditions
- Recurrent malignant brain tumor
- Registration Number
- JPRN-UMIN000003692
- Lead Sponsor
- Department of Neurosurgery Institute of Clinical Medicine Graduate School of Comprehensive Human Sciences University of Tsukuba
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patient with dissemination. 2)AST,ALT > 100IU/ml , Bilirubin > 2.0mg% BUN > 30mg/dl , Cr > 1.8mg% WBC < 2500/mm3 , Plt < 75000/mm3 , Hb < 8g/dl 3)irradiated > 70Gy-Eq to the lesion or normal brain tissue as a previous treatment. 4)There are other malignanicies. 5)The patients with phenylcetonuria. 6)Patients who have complications that are considered inappropriate for the trial. 7)Responsible doctors judged the patient inappropriate for the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety Overall survival
- Secondary Outcome Measures
Name Time Method Progression free survival Tumor control rate, local control rate QOL, neurological function