INTRAGO-I: studio di escalation della dose della radioterapia intraoperatoria (IORT) nel glioblastoma multiforme (GBM)
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La lettura di questa breve panoramica non sostituisce la lettura dello studio originale, ma fornisce solo una visione sintetica e non riflette necessariamente l’opinione degli organismi notificati e/o delle autorità di regolamentazione, quali DQS o FDA.
Una breve panoramica dello studio di escalation della dose INTRAGO-I creata dal Dr. Frank A. Giordano per conto di ZEISS, marzo 2019.
Titolo originale:
INTRAGO: intraoperative radiotherapy in glioblastoma multiforme – a Phase I/II dose escalation study
Autori:
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.
- Il glioblastoma multiforme (GBM) è il tumore cerebrale maligno primario più frequente negli adulti. Quasi tutti i GBM presentano una recidiva, con il rischio maggiore nel letto tumorale.
- Seguendo il protocollo di trattamento standard per il GBM primario, il tempo di sopravvivenza libera da progressione locale è di 7 mesi in media, con una sopravvivenza globale tipica di circa 15 mesi.
- INTRAGO è il primo studio di fase I/II di escalation della dose per GBM di nuova diagnosi che studia l’aggiunta della radioterapia intraoperatoria (IORT) al trattamento radio-chemioterapico standard per GBM con diagnosi recente utilizzando il dispositivo INTRABEAM® di Carl Zeiss Meditec AG.
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