Glioblastoma Multiforme Clinical Trial
Official title:
INTRAGO-Intraoperative Radiotherapy for Glioblastoma - a Phase I/II Study
Glioblastoma multiforme (GBM) is a disease with an extremely poor prognosis. Despite surgery
and radiochemotherapy, the tumors are likely to grow back very quickly.
Intraoperative radiotherapy (IORT) may improve local control rates while sparing healthy
tissue (Giordano et al. 2014). IORT takes place before cranioplasty directly after gross (or
subtotal) tumor resection. Several past studies on IORT for GBM conducted in Japan and Spain
have yielded encouraging results (Sakai et al. 1989; Matsutani et al. 1994; Fujiwara et al.
1995; Ortiz de Urbina et al. 1995).
However, the full potential of the procedure is to date largely unexplored as most previous
studies used forward-scattering (electron-based) irradiation techniques, which frequently
led to inadequately covered target volumes. With the advent of the spherically irradiation
devices such as the Intrabeam® system (Carl Zeiss Meditec AG, Oberkochen, Germany), even
complex cavities can be adequately covered with irradiation during IORT. However, there is
no data on the maximum tolerated dose of IORT with low-energy X-rays as generated by this
system.
The INTRAGO I/II study aims to find out which dose of a single shot of radiation, delivered
intraoperatively direct after surgery, is tolerable for patients with GBM. A secondary goal
of the study is to find out whether the procedure may improve survival rates.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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