Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004015
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of boron neutron capture therapy following surgery in treating patients with glioblastoma multiforme removed during surgery.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: sodium borocaptate Procedure: adjuvant therapy Phase 1

Detailed Description:


  • Determine systemic and local toxicity of borocaptate sodium with boron neutron capture therapy (BNCT) following craniotomy with gross total resection in patients with glioblastoma multiforme.
  • Determine the qualitative and quantitative dose-limiting toxicity and maximum tolerated dose of this regimen in these patients.
  • Determine the maximum tolerated radiation dose of BNCT in cranial localization to healthy tissues in these patients under defined conditions.

OUTLINE: This is a dose escalation, multicenter study.

Within 6 weeks of surgery, patients receive borocaptate sodium followed 12-18 hours later by neutron irradiation. Treatment repeats daily for 4 days.

Cohorts of 3-9 patients receive escalating doses of neutron irradiation. The maximum tolerated dose is defined as the dose preceding that at which 3 or more patients experience dose limiting toxicity.

Patients are followed weekly for 4 weeks, monthly for 2 months, every 6 weeks for 15 months and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 30-36 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Primary Purpose: Treatment
Official Title: Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility
Study Start Date : June 2002
Actual Primary Completion Date : July 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Acute toxicity as measured by NCIC-Common Toxicity Criteria up to 30 days after the first BSH administration

Secondary Outcome Measures :
  1. Late toxicity as measured by RTOC and EORTC late radiation morbidity scale from 90 days after completion of irradiation treatment until death
  2. Overall survival as measured by Logrank until death

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven glioblastoma multiforme for which conventional radiotherapy would be of little or no benefit
  • Gross total resection of tumor confirmed by postoperative MRI performed within 48 hours of surgery
  • Evaluable preoperative and postoperative MRI films with and without contrast must be available
  • No prior brain malignancy
  • No prior craniotomy except for glioblastoma



  • 50 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified


  • Not specified


  • Bilirubin, SGOT, SGPT, and alkaline phosphatase no greater than 2.5 times normal unless caused by reversible reaction to antiseizure medication


  • Blood urea nitrogen and creatinine no greater than 2.5 times upper limit of normal


  • No severe heart disease (e.g., congestive heart failure, angina pectoris)


  • No severe dyspnea at time of diagnosis
  • No severe obstructive or restrictive lung disease


  • No other concurrent malignant tumor
  • No severe gastrointestinal disease or active peptic ulcer disease
  • No uncontrolled endocrine disease
  • No serious mental disease, organic brain disease (e.g., preexisting epilepsy or serious aphasia), or legally incapacitated patients


Biologic therapy:

  • No prior biologic therapy for glioblastoma multiforme
  • No concurrent biologic therapy


  • No prior chemotherapy for glioblastoma multiforme
  • No concurrent chemotherapy

Endocrine therapy:

  • No prior endocrine therapy for glioblastoma multiforme except corticosteroids
  • No concurrent endocrine therapy


  • See Disease Characteristics
  • No prior radiotherapy for glioblastoma multiforme
  • No prior radiotherapy to head and neck
  • No other concurrent radiotherapy


  • See Disease Characteristics
  • Prior stereotactic biopsy allowed for glioblastoma multiforme

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004015

Karl-Franzens-University Graz
Graz, Austria, A-8010
Canada, Ontario
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Hopital Pasteur
Nice, France, 06002
Universitaetsklinikum Essen
Essen, Germany, D-45122
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, Germany, D-81377
Ospedale Santa Chiara Pisa
Pisa, Italy, 56100
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1007 MB
EC Joint Research Centre - Institute for Energy
Petten, Netherlands, NL-1755 ZG
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Wolfgang Sauerwein, MD, PhD Universitaetsklinikum Essen

Publications of Results:
Gabel D, Touw D, Stecher-Rasmussen F, et al.: Quality control of Na2B12H11SH, a drug boron neutron capture therapy in EORTC trial 11961. [Abstract] Ann Oncol 9(suppl 2): 129, 1998.
Hideghety W, Sauerwein W, DeVries M, et al.: Post-operative treatment of glioblastoma with boron neutron capture therapy at the European High Flux Reactor Petten (EORTC protocol 11961). [Abstract] Ann Oncol 9(suppl 2): 129, 1998.
Sauerwein W, Hideghety K, De Vries M, et al.: Boron neutron capture therapy (BNCT) for the treatment of glioblastoma (EORTC protocol 11961). [Abstract] Radiother Oncol 48(suppl 1): s157, 1998.
Sauerwein W, Hideghety K, De Vries M, et al.: Conducting phase I clinical trial in binary treatment modality: methodical questions for the evaluation of boron neutron capture therapy. [Abstract] Ann Oncol 9(suppl 2): 129, 1998.
Haselsberger K, Pendl G, Sauerwein W, et al.: BNCT for glioblastoma in Europe: design of the EORTC protocol 11961 and clinical course of the first patient. [Abstract] J Neurooncol 39 (2): A-P155, 147, 1998.

Other Publications:

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00004015     History of Changes
Other Study ID Numbers: EORTC-11961
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 18, 2012
Last Verified: July 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases