Boron Neutron Capture Therapy, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Recruitment status was Recruiting
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 different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving boron neutron capture therapy followed by radiation therapy and temozolomide may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving boron neutron capture therapy together with radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme.
Brain and Central Nervous System Tumors
Procedure: adjuvant therapy
Radiation: boron neutron capture therapy
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Multicenter, Study for Newly Diagnosed Glioblastomas Using Boron Neutron Capture Therapy, Additional X-ray Treatment and Chemotherapy|
- Overall survival [ Designated as safety issue: No ]
- Tumor response [ Designated as safety issue: No ]
- Adverse effects [ Designated as safety issue: Yes ]
|Study Start Date:||September 2009|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974987
|Osaka Medical College||Recruiting|
|Takatsuki, Osaka, Japan, 569-8686|
|Contact: Shin-Ichi Miyatake, MD, PhD 81-72-683-1221|
|Principal Investigator:||Shin-Ichi Miyatake, MD, PhD||Osaka Medical College|