Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma (INTRAGO): An Open-Label, Dose-Escalation Phase I/II Trial

Giordano, Frank A.; Brehmer, Stefanie; Mürle, Bettina; Welzel, Grit; Sperk, Elena; Keller, Anke; Abo-Madyan, Yasser; Scherzinger, Elisabeth; Clausen, Sven; Schneider, Frank; Herskind, Carsten; Glas, Martin; Seiz-Rosenhagen, Marcel; Groden, Christoph; Hänggi, Daniel; Schmiedek, Peter; Emami, Bahman; Souhami, Luís; Petrecca, Kevin; Wenz, Frederik

doi:10.1093/neuros/nyy018

Cited by 45 publications

(39 citation statements)

References 40 publications

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“…Radionecrosis was judged to be present in 13 patients (25.5%), which is in line with previous findings in a phase I/II trial (15). RN was scored to be of grade 1 RN in 4 patients (7.8%) and of grade 3 in 9 patients (17.6%).…”

Section: Toxicity Profilesupporting

confidence: 88%

“…In contrast to intraoperative electron radiotherapy (IOeRT), that may leave several aspects of the cavity uncovered [31,32], a more intuitive approach is to modify the dose distribution and to spherically cover the cavity with low-energy X-rays [33]. In a recent phase I/II trial, this novel approach of local dose escalation yielded a median progression free survival of 11.2 months and a median local progression-free survival of 14.3 months, with isolated distant recurrence as predominant pattern of failure [15].…”

Section: Discussionmentioning

confidence: 99%

“…Only patients with confirmed pathology diagnosis of GB were included in the analysis. IORT was delivered as described previously after frozen sections supported the preliminary diagnosis of glioblastoma [14,15]. In brief, 50-kV X-rays (INTRABEAM, Carl Zeiss Meditec AG, Oberkochen, Germany) were applied using spherical applicators (size range 1.5-5 cm) at dose levels ranging from 10 to 40 Gy prescribed to the surgical margin (0 cm depth, i.e.…”

Section: Methodsmentioning

confidence: 99%

“…Recently a prospective, single-arm phase I/II study was conducted to determine the safety and efficacy of IORT with lowenergy X-rays added to standard of care adjuvant therapy (radiochemotherapy and maintenance chemotherapy) [14]. It was shown that the addition of IORT was not only tolerable, but also yielded a median local progression-free survival of roughly 18 months despite a high portion of patients with post-operative residual disease (13 of 15) and unmethylated MGMT promoters (10 of 15) in the trial [15].…”

Section: Intraoperative Radiotherapy Dose-escalated Boost Glioblastommentioning

confidence: 99%

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Intraoperative radiotherapy for glioblastoma: an international pooled analysis

Sarria

Sperk

Han

et al. 2020

Radiotherapy and Oncology

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Section: Toxicity Profilesupporting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Intraoperative Radiotherapy Dose-escalated Boost Glioblastommentioning

confidence: 99%

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Intraoperative radiotherapy for glioblastoma: an international pooled analysis

Sarria

Sperk

Han

et al. 2020

Radiotherapy and Oncology

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“…However, with modern application possibilities such as Zeiss Intrabeam, using a sphere-shaped kV-application device, there is a convincing rationale for re-evaluation. Currently, intraoperative dose escalation is being evaluated in a prospective randomized trial [ 54 ].…”

Section: Resultsmentioning

confidence: 99%

Human Glioma Migration and Infiltration Properties as a Target for Personalized Radiation Medicine

Wank

Schilling

Schmid

et al. 2018

Cancers

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Gliomas are primary brain tumors that present the majority of malignant adult brain tumors. Gliomas are subdivided into low- and high-grade tumors. Despite extensive research in recent years, the prognosis of malignant glioma patients remains poor. This is caused by naturally highly infiltrative capacities as well as high levels of radio- and chemoresistance. Additionally, it was shown that low linear energy transfer (LET) irradiation enhances migration and invasion of several glioma entities which might counteract today’s treatment concepts. However, this finding is discussed controversially. In the era of personalized medicine, this controversial data might be attributed to the patient-specific heterogeneity that ultimately could be used for treatment. Thus, current developments in glioma therapy should be seen in the context of intrinsic and radiation-enhanced migration and invasion. Due to the natural heterogeneity of glioma cells and different radiation responses, a personalized radiation treatment concept is suggested and alternative radiation concepts are discussed.

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Intraoperative radiation therapy with 50 kV x‐rays: A multi‐institutional review

Sethi,

Gros,

Brodin

et al. 2024

J Applied Clin Med Phys

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This report covers clinical implementation of a low kV intraoperative radiation therapy (IORT) program with the INTRABEAM® System (Carl Zeiss Meditec AG, Jena, Germany). Based on collective user experience from eight institutions, we discuss best methods of INTRABEAM quality assurance (QA) tests, commissioning measurements, clinical workflow, treatment planning, and potential avenues for research. The guide provides pertinent background information and clinical justification for IORT. It describes the INTRABEAM system and commissioning measurements along with a TG100 risk management analysis to ensure safety and accuracy of the IORT program. Following safety checks, dosimetry measurements are performed for verification of field flatness and symmetry, x‐ray output, and depth dose. Also discussed are dose linearity checks, beam isotropy, ion chamber measurements, calibration protocols, and in‐vivo dosimetry with optically stimulated luminescence dosimeters OSLDs, and radiochromic film. Emphasis is placed on the importance of routine QA procedures (daily, monthly, and annual) performed at regular intervals for a successful IORT program. For safe and accurate dose delivery, tests of important components of IORT clinical workflow are emphasized, such as, dose prescription, pre‐treatment QA, treatment setup, safety checks, radiation surveys, and independent checks of delivered dose. Challenges associated with in‐vivo dose measurements are discussed, along with special treatment procedures and shielding requirements. The importance of treatment planning in IORT is reviewed with reference to a Monte Carlo‐based commercial treatment planning system highlighting its main features and limitations. The report concludes with suggested topics for research including CT‐based image‐guided treatment planning and improved prescription dose accuracy. We hope that this multi‐institutional report will serve as a guidance document on the clinical implementation and use of INTRABEAM IORT.

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Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma (INTRAGO): An Open-Label, Dose-Escalation Phase I/II Trial

Abstract: These data suggest that IORT is associated with manageable toxicity. Considering the limitations of a 15-patient phase I/II trial, further studies aimed at assessing an outcome benefit are warranted.

Cited by 45 publications

References 40 publications

Intraoperative radiotherapy for glioblastoma: an international pooled analysis

Intraoperative radiotherapy for glioblastoma: an international pooled analysis

Human Glioma Migration and Infiltration Properties as a Target for Personalized Radiation Medicine

Intraoperative radiation therapy with 50 kV x‐rays: A multi‐institutional review

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