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

Phase 2

Completed

• Conditions: Brain and Central Nervous System Tumors
• Interventions: Radiation: BNCT(boron neutron capture therapy); Radiation: XRT(X-ray radiation treatment); Drug: TMZ(temozolomide)

• Registration Number: NCT00974987
• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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 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.

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.

* 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 Timeline

• Study Start: 2009-09-01
• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Primary Completion: 2016-02-29
• Study Completion: 2016-02-29
• Status Verified: 2017-06
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	TMZ(temozolomide)	BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide) treatment
Treatment group	BNCT(boron neutron capture therapy)	BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide) treatment
Treatment group	XRT(X-ray radiation treatment)	BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide) treatment

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Time to death from BSH injection（up to 6 years）

Secondary Outcome Measures

Name	Time	Method
Tumor response（RECIST）	From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks
Disease Control Rate (DCR)	From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks
Objective Response Rate (ORR)	From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks
Adverse event	Time to final follow-up survey from the date of enrollment

Trial Locations

Locations (1)

Osaka Medical College; 🇯🇵 Takatsuki, Osaka, Japan