Status:
COMPLETED
Boron Neutron Capture Therapy, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Lead Sponsor:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborating Sponsors:
Department of Nuerosurgery, Osaka Medical College
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
15-75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Boron neutron capture therapy and radiation therapy use high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in differ...
Detailed Description
OBJECTIVES: * Evaluate the overall survival of patients with newly diagnosed glioblastoma multiforme treated with boron neutron capture therapy, radiotherapy, and concurrent and adjuvant temozolomide...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2016
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00974987
Start Date
September 1 2009
End Date
February 29 2016
Last Update
April 25 2018
Active Locations (1)
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1
Osaka Medical College
Takatsuki, Osaka, Japan, 569-8686