Evidence map›Paper›PMID 30417218›Full record

ArticleJournal of cancer research and clinical oncology2019

Safety of pioglitazone during and after radiation therapy in patients with brain tumors: a phase I clinical trial.

Christina K Cramer, Natalie Alphonse-Sullivan, Scott Isom, Linda J Metheny-Barlow, Tiffany L Cummings, Brandi R Page, Doris R Brown, Arthur W Blackstock, Ann M Peiffer, Roy E Strowd and 4 more

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal of cancer research and clinical oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.8field-weighted citation impact, top 14% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 22 citations in OpenAlex.

  1. Review
  2. Obstacles and Trials in Treating Primary Brain Tumors.International journal of molecular sciences · 2026
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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

14 authors at 3 institutions in 1 country.

Christina K CramerDepartment of Radiation Oncology, Wake Forest School of Medicine, 1 Medical Center Blvd, Winston-Salem, NC, 27157, USA. ccramer@wakehealth.edu.ORCID http://orcid.org/0000-0001-7618-3921
Natalie Alphonse-SullivanDepartment of Radiation Oncology, Wake Forest School of Medicine, 1 Medical Center Blvd, Winston-Salem, NC, 27157, USA.
Scott IsomDepartment of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC, 27157, USA.
Linda J Metheny-BarlowDepartment of Radiation Oncology, Wake Forest School of Medicine, 1 Medical Center Blvd, Winston-Salem, NC, 27157, USA.
Tiffany L CummingsDepartment of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, 27157, USA.
Brandi R PageDepartment of Radiation Oncology, Johns Hopkins School of Medicine, Baltimore, MD, 21287, USA.
Doris R BrownDepartment of Radiation Oncology, Wake Forest School of Medicine, 1 Medical Center Blvd, Winston-Salem, NC, 27157, USA.
Arthur W BlackstockDepartment of Radiation Oncology, Wake Forest School of Medicine, 1 Medical Center Blvd, Winston-Salem, NC, 27157, USA.
Ann M PeifferDepartment of Psychology, Mars Hill University, Mars Hill, NC, 28754, USA.
Roy E StrowdDepartment of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, 27157, USA.
Stephen RappDepartment of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, NC, 27157, USA.
Glenn J LesserDepartment of Internal Medicine (Hematology & Oncology), Wake Forest School of Medicine, Winston-Salem, NC, 27157, USA.
Edward G ShawDepartment of Internal Medicine (Gerontology and Geriatrics), Wake Forest School of Medicine, Winston-Salem, NC, 27157, USA.
Michael D ChanDepartment of Radiation Oncology, Wake Forest School of Medicine, 1 Medical Center Blvd, Winston-Salem, NC, 27157, USA.
Wake Forest University · USJohns Hopkins University · USMars Hill University · US

Funding

Wake Forest NCORP Research BaseUG1CA189824 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Emily Van Meter Dressler, GLENN J LESSER · 2014 to 2026
$57.9M
Tumor Tissue CoreP30CA012197 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Ruben A. Mesa · 1985 to 2026
$55.4M
NCI NIH HHS P30 CA012197NCI NIH HHS P30 CA012197-40NCI NIH HHS UG1 CA189824
6 · The paper itself

Abstract

introductionRadiation-induced cognitive decline (RICD) is a late effect of radiotherapy (RT) occurring in 30-50% of irradiated brain tumor survivors. In preclinical models, pioglitazone prevents RICD but there are little safety data on its use in non-diabetic patients. We conducted a dose-escalation trial to determine the safety of pioglitazone taken during and after brain irradiation.

methodsWe enrolled patients > 18 years old with primary or metastatic brain tumors slated to receive at least 10 treatments of RT (≤ 3 Gy per fraction). We evaluated the safety of pioglitazone at 22.5 mg and 45 mg with a dose-escalation phase and dose-expansion phase. Pioglitazone was taken daily during RT and for 6 months after.

results18 patients with a mean age of 54 were enrolled between 2010 and 2014. 14 patients had metastatic brain tumors and were treated with whole brain RT. Four patients had primary brain tumors and received partial brain RT and concurrent chemotherapy. No DLTs were identified. In the dose-escalation phase, there were only three instances of grade ≥ 3 toxicity: one instance of neuropathy in a patient receiving 22.5 mg, one instance of fatigue in a patient receiving 22.5 mg and one instance of dizziness in a patient receiving 45 mg. The attribution in each of these cases was considered "possible." In the dose-expansion phase, nine patients received 45 mg and there was only one grade 3 toxicity (fatigue) possibly attributable to pioglitazone.

conclusionPioglitazone was well tolerated by brain tumor patients undergoing RT. 45 mg is a safe dose to use in future efficacy trials.

Indexed as

AdultAgedAged, 80 and overBrain NeoplasmsFemaleFollow-Up StudiesHumansHypoglycemic AgentsLymphatic MetastasisMaleMaximum Tolerated DoseMiddle AgedPatient SafetyPioglitazonePrognosisRadiotherapy, ConformalHypoglycemic AgentsPioglitazoneNeuroprotectivePioglitazoneRadiation-induced cognitive decline

Identifiers

PMID30417218
PMCPMC6805132
OpenAlexW2900731820

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

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.