Evidence map›Paper›PMID 41107078›Full record

Trial reportBrachytherapy

Image guided brachytherapy quality assurance on NRG GY017 investigating immunotherapy in addition to chemoradiation for locally advanced cervical cancer.

Hayeon Kim, Wei Deng, Dimitriy Zamarin, Ying Xiao, Junzo Chino, Stanley Benedict, Hannah Nguyen, Jessica Lowenstein, Susan McNulty, Sharad Ghamande and 13 more

Abstract readRandomized Controlled TrialClinical Trial, Phase I
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
–field-weighted citation impact
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.

  1. Trial
  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

23 authors.

Hayeon KimUPMC Hillman Cancer Center, Department of Radiation Oncology, University of Pittsburgh School of Medicine, Pittsburgh, PA.
Wei DengNRG Statistical Center, Dept. of Biostatistics and Bioinformatics, Roswell Park Cancer Institute, Buffalo, NY.
Dimitriy ZamarinIcahn School of Medicine at Mount Sinai, Dept. of Hematology/Oncology, New York, NY.
Ying XiaoUniversity of Pennsylvania, Department of Radiation Oncology, Philadelphia, PA.
Junzo ChinoDuke University, Department of Radiation Oncology, Durham, NC.
Stanley BenedictVirginia Commonwealth University, Department of Radiation Oncology, Richmond, VA.
Hannah NguyenMD Anderson Medical Center, IROC Houston QA Center, Houston, TX.
Jessica LowensteinMD Anderson Medical Center, IROC Houston QA Center, Houston, TX.
Susan McNultyAmerican College of Radiology, Department of IROC, Phila QA center, Philadelphia, PA.
Sharad GhamandeAugusta University Medical College of Georgia, Wellstar Gynecologic Oncology, Augusta, GA.
Catherine FergusonAugusta University Medical College of Georgia, Wellstar Radiation Oncology, Augusta, GA.
Loren MellUniversity of California San Diego, Moores Cancer Center, Department of Radiation Oncology, San Diego, CA.
Laura L HolmanUniversity of Oklahoma Health Sciences Center, Stephenson Cancer Center, Department of Gynecologic Oncology, Oklahoma, OK.
Cara MathewsWomen & Infants Hospital, Department of Gynecologic Oncology, Legorreta Cancer Center, Alpert Medical School of Brown University, Providence, RI.
Allison QuickThe Ohio State University Medical Center, Department of Radiation Oncology, Columbus, OH.
Alexander OlawaiyeUniversity of Pittsburgh, Magee-Women Hospital of UPMC, Department of OB/GYN, Pittsburgh, PA.
Elizabeth HoppMedical College of Wisconsin, Cancer Center - Froedtert Hospital, Department of Gynecologic Oncology, Milwaukee, WI.
Robert MannelThe University of Oklahoma Health Sciences, College of Medicine, Department of OB/GYN, Stephenson Cancer Center, Oklahoma, OK.
Charles A. Leath IIIUniversity of Alabama at Birmingham, O'Neal Comprehensive Cancer Center, Department of Obstetrics & Gynecology, Birmingham, AL.
Roisin-E O'CearbhaillMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, Department of Medicine, New York, NY.
Carol AghajanianMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, Department of Medicine, New York, NY.
Russell J SchilderThomas Jefferson University, Department of Gynecologic Medical Oncology, Philadelphia, PA.
Jyoti MayadevRadiation Medicine and Applied Sciences, UC San Diego Medical Center, Moores Cancer Center, La Jolla, CA. Electronic address: jmayadev@ucsd.edu.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Elaina Harper · 2014 to 2026
$146.4M
IROC: Enhancing local enrolling site radiological data capture capabilities for NCTN trialsU24CA180803 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI Thomas J. FitzGerald, MICHAEL V KNOPP · 2014 to 2026
$116.2M
NRG Oncology Biospecimen BankU24CA196067 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Tanner J. Freeman, Nilsa Del Carmen Ramirez Milan · 2015 to 2026
$42.6M
Immunogenomic predictors of outcomes in patients with locally advanced cervical cancer treated with immunotherapy and chemoradiationR01CA276087 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI ZAMARIN, DMITRIY · 2023 to 2025
$1.7M
NCI Clinical Trial Research Strategy, Harnessing of Equity, and ImplementationR50CA282102 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Jyoti Mayadev · 2023 to 2026
$696k
NCI NIH HHS P30 CA008748NCI NIH HHS R01 CA276087NCI NIH HHS R50 CA282102NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA180803NCI NIH HHS U24 CA196067
6 · The paper itself

Abstract

introductionBrachytherapy is a critical component of curative treatment in locally advanced cervical cancer. NRG GY-017 is a randomized Phase I trial of the anti-PD-L1 antibody atezolizumab administered neoadjuvantly and concurrently with chemoradiation (Arm A) or only concurrently with chemoradiation (Arm B) in patients with node positive locally advanced cervical cancer. Image guided brachytherapy (IGBT) was mandated in the protocol with a quality assurance (QA) workflow. Herein, we report the BT quality data on NRG GY-017 trial and practice patterns from the participating centers in this trial as a guide for future protocol brachytherapy QA.

methodsThe participating sites were to submit brachytherapy plans online after BT was completed. IROC QA center compiled the BT fractions for each patient using the trial specific dosimetry evaluation template. An expert physician reviewer scored the contours and plans as per protocol, variation acceptable or major deviation as prespecified in the protocol dose metrics.

resultsThe BT dosimetry results were available for 32 patients. Seventeen patients (53%) had intracavitary applicator, and 15 patients (47%) had hybrid or interstitial applicators. Point A directed planning was performed for 4 patients (12.5%) and 28 patients had volume directed plans (87.5%). For imaging use, 2 patients had MRI based plans, and 30 had CT based planning (94%). For the dose constraints compliance per protocol, 7 patients had 9 events scored as major deviations (22%).

conclusionBT trial specific QA has the potential to enhance BT quality for clinical trials. This report will help guide future gynecologic BT trial data collection and QA process.

Indexed as

Antibodies, Monoclonal, HumanizedBrachytherapyChemoradiotherapyImmunotherapyQuality Assurance, Health CareRadiotherapy, Image-GuidedUterine Cervical NeoplasmsFemaleHumansRadiotherapy DosageRadiotherapy Planning, Computer-AssistedAntibodies, Monoclonal, HumanizedatezolizumabBrachytherapyCervical cancerClinical trialsPeer reviewQuality assuranceRadiation

Identifiers

PMID41107078
PMCPMC12971087

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.