Reading this brief overview does not substitute the reading of the original study, but is just giving an abridged insight and is not necessarily reflecting the opinion of notified bodies and/or regulatory authorities, such as the DQS or FDA.
A brief overview of the INTRAGO-I dose escalation study created by Dr. Frank A. Giordano on behalf of ZEISS, March 2019.
INTRAGO: intraoperative radiotherapy in glioblastoma multiforme – a Phase I/II dose escalation study
Frank A. Giordano, Stefanie Brehmer, Yasser Abo-Madyan, Grit Welzel, Elena Sperk, Anke Keller,
Frank Schneider, Sven Clausen, Carsten Herskind, Peter Schmiedek, Frederik Wenz
Giordano, F. A., Brehmer, S., Abo-Madyan, Y., Welzel, G., Sperk, E., Keller, A., … Wenz, F. (2014).
INTRAGO: intraoperative radiotherapy in glioblastoma multiforme – a Phase I/II dose escalation study.
BMC Cancer, 14(1), 992.
- Glioblastoma multiforme (GBM) is the main primary malignant brain tumor in adults. Almost all GBM show a recurrence with the highest risk in the tumor bed.
- Following the standard treatment protocol for primary GBM, the local progression-free survival time is 7 months in median with a typical overall survival of around 15 months.1
- INTRAGO is the first phase I/II dose-escalation study for newly diagnosed GBM investigating the addition of intraoperative radiation therapy (IORT) to the standard radio-chemotherapy treatment for newly diagnosed GBM using the INTRABEAM® device of Carl Zeiss Meditec AG.