Evidence map›Paper›PMID 25535398›Full record

Trial reportBMC cancer2014

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 and 1 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02104882 phase1 / phase2completednot on this map

INTRAGO-Intraoperative Radiotherapy for Glioblastoma - a Phase I/II Study

TypeinterventionalSponsorUniversitätsmedizin MannheimRan2014 to 2016Enrolled12ConditionsGlioblastoma MultiformeArmsIntraoperative Radiotherapy (Applicator Surface Dose: 20-40 Gy)
NCT02685605 phase3active not recruitingnot on this mapstarted 2016, after this paper: background citation

A Multicenter Randomized Phase III Trial on INTraoperative RAdiotherapy in Newly Diagnosed GliOblastoma Multiforme (INTRAGO II)

TypeinterventionalSponsorUniversitätsmedizin MannheimRan2016 to 2026Enrolled314ConditionsGlioblastomaArmsStandard surgery, Intraoperative radiotherapy, Radiochemotherapy, Temozolomide
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 53 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 2 countries.

Frank A GiordanoDepartment of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany. frank.giordano@umm.de.
Stefanie Brehmer
Yasser Abo-Madyan
Grit Welzel
Elena Sperk
Anke Keller
Frank Schneider
Sven Clausen
Carsten Herskind
Peter Schmiedek
Frederik Wenz
University Hospital Heidelberg · DEHeidelberg University · DEUniversity Medical Centre Mannheim · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlioblastoma multiforme (GBM) is the most frequent primary malignant brain tumor in adults. Despite multimodal therapies, almost all GBM recur within a narrow margin around the initial resected lesion. Thus, novel therapeutic intensification strategies must target both, the population of dispersed tumor cells around the cavity and the postoperative microenvironment. Intraoperative radiotherapy (IORT) is a pragmatic and effective approach to sterilize the margins from persistent tumor cells, abrogate post-injury proliferative stimuli and to bridge the therapeutic gap between surgery and radiochemotherapy. Therefore, we have set up INTRAGO, a phase I/II dose-escalation study to evaluate the safety and tolerability of IORT added to standard therapy in newly diagnosed GBM. In contrast to previous approaches, the study involves the application of isotropic low-energy (kV) x-rays delivered by spherical applicators, providing optimal irradiation properties to the resection cavity. METHODS/

designINTRAGO includes patients aged 50 years or older with a Karnofsky performance status of at least 50% and a histologically confirmed (frozen sections) supratentorial GBM. Safety and tolerability (i.e., the maximum tolerated dose, MTD) will be assessed using a classical 3 + 3 dose-escalation design. Dose-limiting toxicities (DLT) are wound healing deficits or infections requiring surgical intervention, IORT-related cerebral bleeding or ischemia, symptomatic brain necrosis requiring surgical intervention and early termination of external beam radiotherapy (before the envisaged dose of 60 Gy) due to radiotoxicity. Secondary end points are progression-free and overall survival.

trial registrationThe study is registered with clinicaltrials.gov, number: NCT02104882 (Registration Date: 03/26/2014).

Indexed as

Clinical ProtocolsIntraoperative CareBrain NeoplasmsCombined Modality TherapyGlioblastomaHumansRadiographyRadiotherapy Dosage

Identifiers

PMID25535398
PMCPMC4364103
OpenAlexW2112107405

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.