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International Journal of Clinical Oncology

Erschienen in:

01.10.2013 | Original Article

Accelerated intensity-modulated radiotherapy plus temozolomide in patients with glioblastoma: a phase I dose-escalation study (ISIDE-BT-1)

verfasst von: Mariangela Massaccesi, Marica Ferro, Savino Cilla, Mario Balducci, Francesco Deodato, Gabriella Macchia, Vincenzo Valentini, Alessio G. Morganti

Erschienen in: International Journal of Clinical Oncology | Ausgabe 5/2013

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Abstract

Background

We performed a dose-escalation trial to determine the maximum tolerated dose (MTD) of intensity-modulated radiotherapy (IMRT) with standard concurrent and sequential-dose temozolomide (TMZ) in patients with glioblastoma multiforme.

Methods

Histologically proven glioblastoma patients underwent IMRT dose escalation. IMRT was delivered over 5 weeks with the simultaneous integrated boost (SIB) technique to the two planning target volumes (PTVs) defined by adding 5-mm margin to the respective clinical target volumes (CTVs). CTV1 was the tumor bed plus the enhancing lesion with 10-mm margin; CTV2 was the area of perifocal edema with 20-mm margin. Only the PTV1 dose was escalated (planned dose escalation: 60, 62.5, 65, 67.5, 70 Gy) while the PTV2 dose remained the same (45 Gy).

Results

Forty consecutive glioblastoma patients were treated. While no dose-limiting toxicity (DLT) was recorded during the dose escalation up to 67.5/2.7 Gy, two out of the first six consecutively enrolled patients on the highest dose level (70/2.8 Gy) experienced a DLT, and therefore a cohort expansion was required. 3/14 patients experienced a DLT on the highest planned dose level, and therefore the MTD was not exceeded. After a median follow-up time of 25 months no grade >2 late neurological toxicity was recorded.

Conclusions

By using a SIB IMRT technique, a radiation dose of 70 Gy in 25 fractions (biological effective dose—BED—of 92.8 Gy) can be delivered with concurrent and sequential standard dose TMZ, without unacceptable acute toxicity in patients with glioblastoma.

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Titel: Accelerated intensity-modulated radiotherapy plus temozolomide in patients with glioblastoma: a phase I dose-escalation study (ISIDE-BT-1)
verfasst von: Mariangela Massaccesi
Marica Ferro
Savino Cilla
Mario Balducci
Francesco Deodato
Gabriella Macchia
Vincenzo Valentini
Alessio G. Morganti
Publikationsdatum: 01.10.2013
Verlag: Springer Japan
Erschienen in: International Journal of Clinical Oncology / Ausgabe 5/2013
Print ISSN: 1341-9625
Elektronische ISSN: 1437-7772
DOI: https://doi.org/10.1007/s10147-012-0462-0

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Accelerated intensity-modulated radiotherapy plus temozolomide in patients with glioblastoma: a phase I dose-escalation study (ISIDE-BT-1)