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Brain and Central Nervous System TumorsPhase 2NCT00974987

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

A Phase 2 study testing BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide) in people with Brain and Central Nervous System Tumors, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 15 to 75 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteJapan
Study dates
1 Sep 2009to 29 Feb 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Osaka Medical College

    Takatsuki, Osaka, 569-8686

Other trials in Japan

About this study

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

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.

Read the 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.

Being tested
BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment), TMZ(temozolomide)
Keywords
adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma
Medical subject headings
Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BNCT(boron neutron capture therapy)Radiation

    BSH(sodium borocaptate) 100mg/kg iv for one hour starting 13 hours before irradiation, and BPA(p-boronophenylalanine) 500/mg/kg iv at a speed of 200mg/kg/hr for 2 hours starting 2 hours before irradiation. During irradiation, BPA iv continues at a speed of 100mg/kg/hr.

  • XRT(X-ray radiation treatment)Radiation

    After BNCT, 2Gy irradiation every day for 12 days.

  • TMZ(temozolomide)Drug

    75mg/m2 for day1-12. After XRT, repeat the cycle of 150-200mg/m2 for 5 days and cessation for 23 days.

Study groups in NCT00974987
Study groupRoleWhat they receive
Treatment groupExperimentalBNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide) treatment
Receives: Radiation: BNCT(boron neutron capture therapy); Radiation: XRT(X-ray radiation treatment); Drug: TMZ(temozolomide)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    Measured: Time to death from BSH injection（up to 6 years）

Secondary outcomes (4)

  1. Tumor response（RECIST）

    Measured: From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks

  2. Objective Response Rate (ORR)

    Measured: From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks

  3. Disease Control Rate (DCR)

    Measured: From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks

  4. Adverse event

    Measured: Time to final follow-up survey from the date of enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2009 (estimated)
  2. Study start1 Sep 2009
  3. Primary completion29 Feb 2016
  4. Study completion29 Feb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00974987
Sponsor's protocol ID
OSAKA-TRIBRAIN0902
Other IDs
CDR0000650829, UMIN000002385
Status last verified
Jun 2017
First submitted
10 Sep 2009
Last updated
25 Apr 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Kawabata S, Miyatake S, Hiramatsu R, Hirota Y, Miyata S, Takekita Y, Kuroiwa T, Kirihata M, Sakurai Y, Maruhashi A, Ono K. Phase II clinical study of boron neutron capture therapy combined with X-ray radiotherapy/temozolomide in patients with newly diagnosed glioblastoma multiforme--study design and current status report. Appl Radiat Isot. 2011 Dec;69(12):1796-9. doi: 10.1016/j.apradiso.2011.03.014. Epub 2011 Mar 21.

    PubMed 21459588

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide) in people with Brain and Central Nervous System Tumors, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: Time to death from BSH injection（up to 6 years）). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00974987, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2018.

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