INTRAGO-I: estudo de escalonamento de dose de radioterapia intraoperatória (IORT) para glioblastoma multiforme (GBM)
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A leitura desta breve síntese não substitui a leitura do estudo original, dá apenas uma visão resumida e não reflete necessariamente a opinião dos organismos notificados e/ou das autoridades reguladoras, tais como a DQS ou a FDA.
Breve apresentação geral do estudo de escalonamento de dose INTRAGO-I criado pelo Dr. Frank A. Giordano em nome da ZEISS, março de 2019.
Título original:
INTRAGO: intraoperative radiotherapy in glioblastoma multiforme – a Phase I/II dose escalation study
Autores:
Frank A. Giordano, Stefanie Brehmer, Yasser Abo-Madyan, Grit Welzel, Elena Sperk, Anke Keller,
Frank Schneider, Sven Clausen, Carsten Herskind, Peter Schmiedek, Frederik Wenz
Fonte:
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.
- O glioblastoma multiforme (GBM) é o principal tumor cerebral maligno primário em adultos. Quase todos os GBM apresentam uma recidiva com o risco mais elevado a nível do leito do tumor.
- Seguindo o protocolo de tratamento padrão para o GBM primário, o tempo de sobrevivência sem progressão local tem uma mediana de 7 meses, com uma sobrevivência global típica de cerca de 15 meses.
- O INTRAGO é o primeiro estudo de fase I/II de escalonamento da dose para GBM recentemente diagnosticado que investiga a adição de radioterapia intraoperatória (IORT) ao tratamento padrão de radioquimioterapia para GBM recentemente diagnosticado utilizando o dispositivo INTRABEAM® da Carl Zeiss Meditec AG.
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