A Phase II, Multicenter, Study for Newly Diagnosed Glioblastomas Using Boron Neutron Capture Therapy, Additional X-ray Treatment and Chemotherapy
15 Years
75 Years
Both
Brain and Central Nervous System Tumors
Trial Information
A Phase II, Multicenter, Study for Newly Diagnosed Glioblastomas Using Boron Neutron Capture Therapy, Additional X-ray Treatment and Chemotherapy
OBJECTIVES:
- Evaluate the overall survival of patients with newly diagnosed glioblastoma multiforme
treated with boron neutron capture therapy, radiotherapy, and concurrent and adjuvant
temozolomide.
- Evaluate tumor response in patients treated with this regimen.
- Evaluate the adverse effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo boron neutron capture therapy followed by radiotherapy and concurrent and
adjuvant oral temozolomide.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed glioblastoma multiforme
- Newly diagnosed disease
- Tumor located at a supratentorial hemisphere
- Deepest part of tumor < 6 cm from the scalp
- Bottom of the tumor > 6 cm from the scalp allowed provided air instillation into
tumor-removed cavity is possible
- No cerebrospinal fluid dissemination
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Life expectancy > 3 months
- Leukocyte count ≥ 3,000/μL
- Platelet count ≥ 10.0 × 10^4/μL
- Hemoglobin ≥ 8.0 g/dL
- Serum creatinine ≤ 1.5 mg/dL
- ALT and AST ≤ 100 IU/L
- No phenylketonuria
- Not pregnant or nursing
- No NYHA class III-IV heart failure
- No patient whose participation in the present study is considered inappropriate by a
Principal Investigator or Clinical Investigator
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Safety Issue:
No
Principal Investigator
Shin-Ichi Miyatake, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Osaka Medical College
Authority:
Unspecified
Study ID:
CDR0000650829
NCT ID:
NCT00974987
Start Date:
September 2009
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- adult giant cell glioblastoma
- adult glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
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