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.
Funding SchemeCSC - Cost-sharing contracts
1755 ZG Petten
1755 LE Petten