Boron Neutron Capture Therapy, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Brain and Central Nervous System Tumors Clinical Trial

Official title: A Phase II, Multicenter, Study for Newly Diagnosed Glioblastomas Using Boron Neutron Capture Therapy, Additional X-ray Treatment and Chemotherapy

Status Completed

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. ;

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioblastoma
• Nervous System Neoplasms

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