Glioma trial with boron neutron capture therapy

Objective

To demonstrate the safety and practicability of boron neutron capture therapy (BNCT) as radiotherapy modality.
To demonstrate which are the optimal treatment conditions for glioma treatment with boron neutron capture therapy and Na2B12H11SH (BSH) as boron carrier.
To demonstrate the use of a centralized European treatment center in multi-country treatment.

The proposed Demonstration Project is for a Phase I/II study of glioma treatment with boron neutron capture therapy (BNCT). It has as objective to investigate whether BNCT with epithermal neutrons and Na2B12HllSH (BSH) as boron compound is a safe, and an effective, treatment of glioma. This will be achieved through the treatment of patients, with patient survival and quality of survival as measurable parameters. The study will show what the maximum irradiation level is for safe BNCT with BSH, and whether irradiation at or before maximum tolerated dose will result in partial or complete tumour control. It will be investigated to which extent treatment conditions can influence the outcome for the patients. Emphasis will be put on safety for the patient and effectiveness of treatment. The program will eventually demonstrate whether the therapeutic ratio of BNCT can surpass that of other radiotherapy modalities for glioma. Thus, it falls within area 4.1 Cancer Research subsection 4.1.8 Assessment of treatment modalities. If successful, it will lead to the introduction of a new cancer therapy modality into the clinical reality. The clinical research proposed will therefore facilitate the transition of BNCT into clinical use. It can only be carried out in the framework of a Demonstration Project. Europe has, among the participating partners, all necessary knowledge and experience to carry out the project in a competent and effective manner.

Fields of science

• medical and health sciences › clinical medicine › oncology
• natural sciences › chemical sciences › inorganic chemistry › metalloids

Programme(s)

• FP4-BIOMED 2 - Specific research, technological development and demonstration programme in the field of biomedicine and health, 1994-1998

Topic(s)

• 8.2 - Demonstration

Call for proposal

Data not available

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

UNIVERSITAET BREMEN

Address

Leobener Strasse
28334 Bremen
Germany

Participants (8)

CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS

Switzerland

Address

Rue Du Bugnon 46
1011 Lausanne

Centre Antoine Lacassagne

France

Address

227,avenue De La Lanterne
06200 Nice

Commission of the European Communities

Netherlands

Address

3,westerduinweg
1755 ZG Petten

Karl-Franzens-Universität Graz

Austria

Address

Auenbruggerplatz
8036 Graz

Ludwig-Maximilians-Universität München

Germany

Address

15,marchioninistraße
81366 München

Netherlands Energy Research Foundation

Netherlands

Address

3,westerduinweg
1755 LE Petten

Universität Gesamthochschule Essen

Germany

Address

55,hufelandstrasse
45122 Essen

Zentralkrankenhaus St.-Jürgen-Strasse

Germany

Address

St.-jürgen-strasse
28205 Bremen