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Clinical Trial 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 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.


Clinical Trial 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.

- 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00974987
Study type Interventional
Source Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Contact
Status Completed
Phase Phase 2
Start date September 1, 2009
Completion date February 29, 2016

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