Evidence map›Paper›PMID 38519352›Full record

Trial reportBrachytherapy

A randomized trial evaluating a novel hydrogel packing system compared to standard packing during image-guided high-dose rate brachytherapy boost for cervical cancer.

Kara D Romano, Gina Petroni, Kristi Ward, Wendy Zheng, Matthew Mistro, Bruce Libby, Christopher McLaughlin, Timothy N Showalter, Einsley M Janowski

Open access · greenAbstract readRandomized Controlled TrialComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Brachytherapy. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.7field-weighted citation impact, top 17% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
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

9 authors at 3 institutions in 1 country.

Kara D RomanoDepartment of Radiation Oncology, University of Virginia, Charlottesville, Virginia, USA. Electronic address: ked7c@virginia.edu.
Gina PetroniSchool of Public Health Sciences, Division of Biostatistics, University of Virginia, Charlottesville, Virginia, USA.
Kristi WardDepartment of Radiation Oncology, Emory University, Atlanta, Georgia, USA.
Wendy ZhengDepartment of Radiation Oncology, University of Virginia, Charlottesville, Virginia, USA.
Matthew MistroDepartment of Radiation Oncology, University of Virginia, Charlottesville, Virginia, USA.
Bruce LibbyH. Lee Moffitt Cancer Center, Department of Radiation Oncology, Tampa, Florida, USA.
Christopher McLaughlinDepartment of Radiation Oncology, University of Virginia, Charlottesville, Virginia, USA.
Timothy N ShowalterDepartment of Radiation Oncology, University of Virginia, Charlottesville, Virginia, USA.
Einsley M JanowskiDepartment of Radiation Oncology, University of Virginia, Charlottesville, Virginia, USA.
University of Virginia · USEmory University · USMoffitt Cancer Center · US

Funding

Clinical validation and commercialization of a novel hydrogel-based vaginal packing system for pelvic brachytherapyR42CA203171 · NCI · BRACHYFOAM, LLC · PI SHOWALTER, TIMOTHY NORMAN · 2019 to 2020
$1.5M
NCI NIH HHS R42 CA203171
6 · The paper itself

Abstract

introductionThe purpose of this prospective randomized trial was to compare the use of a novel vaginal hydrogel packing system (BrachyGel) to standard vaginal packing (VP) during high dose rate (HDR) brachytherapy (BT) for locally advanced cervical cancer (LACC).

methodsThis cross-over study included LACC patients receiving HDR BT boost (intracavitary +/- interstitial). All patients received alternating gauze or BrachyGel VP on Arms A and B. Patients, physicians, and physicists evaluated BT characteristics via a 4-point Likert scale. Adverse events (AEs) were prospectively collected and scored per CTCAE.

resultsThe 20 patients enrolled. The mean bladder D2cc difference between gauze and BrachyGel in Arm A was 0.117 Gray (Gy) and in Arm B 0.013 Gy. The mean difference in rectum D2cc in Arm A and Arm B was -0.189 Gy and -0.191 Gy, respectively. The mean dose to 90% of the high-risk clinical target volume (HR-CTV) for gauze compared to BrachyGel was -0.032 Gy (95% CI: 0.472, 0.409). Patient-reported discomfort was similar with BrachyGel and gauze ("mild/moderate" 70.0% vs 74.0%, respectively). The clarity of VP was similar between BrachyGel and gauze (86.8% vs 89.7%, respectively). The completeness of VP was more frequently "excellent/good" with BrachyGel (79.0%) compared to gauze (56.4%). The ease of packing was more frequently "extremely easy" with BrachyGel (21.2% vs 0%). No serious AEs were reported.

conclusionThis randomized trial found no clinically significant difference in OAR or HR-CTV dosimetry between BrachyGel and standard VP. BrachyGel performed well compared to gauze for the patient and physician use experience.

Indexed as

BrachytherapyRadiotherapy DosageUterine Cervical NeoplasmsAdultAgedCross-Over StudiesFemaleHumansHydrogelsMiddle AgedProspective StudiesRadiotherapy, Image-GuidedTreatment OutcomeHydrogelsBrachytherapyCervical cancerRadiation therapyVaginal packing

Identifiers

PMID38519352
PMCPMC11098690
OpenAlexW4393037100

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.