Clinical trial · Interventional
Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery
Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility
NCT00004015CI-TRIAL-00007486completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| sodium borocaptate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Acute toxicity as measured by NCIC-Common Toxicity Criteria up to 30 days after the first BSH administration
Secondary outcomes (2)
- measure
- Late toxicity as measured by RTOC and EORTC late radiation morbidity scale from 90 days after completion of irradiation treatment until death
- measure
- Overall survival as measured by Logrank until death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age: * 50 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin, SGOT, SGPT, and alkaline phosphatase no greater than 2.5 times normal unless caused by reversible reaction to antiseizure medication Renal: * Blood urea nitrogen and creatinine no greater than 2.5 times upper limit of normal Cardiovascular: * No severe heart disease (e.g., congestive heart failure, angina pectoris) Pulmonary: * No severe dyspnea at time of diagnosis * No severe obstructive or restrictive lung disease Other: * 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 PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy for glioblastoma multiforme * No concurrent biologic therapy Chemotherapy: * No prior chemotherapy for glioblastoma multiforme * No concurrent chemotherapy Endocrine therapy: * No prior endocrine therapy for glioblastoma multiforme except corticosteroids * No concurrent endocrine therapy Radiotherapy: * See Disease Characteristics * No prior radiotherapy for glioblastoma multiforme * No prior radiotherapy to head and neck * No other concurrent radiotherapy Surgery: * See Disease Characteristics * Prior stereotactic biopsy allowed for glioblastoma multiforme
References
Publications (16)
- BACKGROUNDWittig A, Moss RL, Stecher-Rasmussen F, Appelman K, Rassow J, Roca A, Sauerwein W. Neutron activation of patients following boron neutron capture therapy of brain tumors at the high flux reactor (HFR) Petten (EORTC Trials 11961 and 11011). Strahlenther Onkol. 2005 Dec;181(12):774-82. doi: 10.1007/s00066-005-1433-4. PMID 16362787
- BACKGROUNDVerbakel WF, Hideghety K, Morrissey J, Sauerwein W, Stecher-Rasmussen F. Towards in vivo monitoring of neutron distributions for quality control of BNCT. Phys Med Biol. 2002 Apr 7;47(7):1059-72. doi: 10.1088/0031-9155/47/7/305. PMID 11996055
- BACKGROUNDHusing J, Sauerwein W, Hideghety K, Jockel KH. A scheme for a dose-escalation study when the event is lagged. Stat Med. 2001 Nov 30;20(22):3323-34. doi: 10.1002/sim.954. PMID 11746321
- BACKGROUNDRassow J, Stecher-Rasmussen F, Voorbraak W, Moss R, Vroegindeweij C, Hideghety K, Sauerwein W. Comparison of quality assurance for performance and safety characteristics of the facility for Boron Neutron Capture therapy in Petten/NL with medical electron accelerators. Radiother Oncol. 2001 Apr;59(1):99-108. doi: 10.1016/s0167-8140(00)00298-x. PMID 11295213
- BACKGROUNDSauerwein W, Moss R, Rassow J, Stecher-Rasmussen F, Hideghety K, Wolbers JG, Sack H. Organisation and management of the first clinical trial of BNCT in Europe (EORTC protocol 11961).EORTC BNCT study group. Strahlenther Onkol. 1999 Jun;175 Suppl 2:108-11. doi: 10.1007/BF03038906. PMID 10394415
- BACKGROUNDGabel D, Philipp KH, Wheeler FJ, Huiskamp R. The compound factor of the 10B(n,alpha)7Li reaction from borocaptate sodium and the relative biological effectiveness of recoil protons for induction of brain damage in boron neutron capture therapy. Radiat Res. 1998 Apr;149(4):378-86. PMID 9525503
- BACKGROUNDPignol JP, Oudart H, Chauvel P, Sauerwein W, Gabel D, Prevot G. Selective delivery of 10B to soft tissue sarcoma using 10B-L-borophenylalanine for boron neutron capture therapy. Br J Radiol. 1998 Mar;71(843):320-3. doi: 10.1259/bjr.71.843.9616243.