Evidence map›Paper›PMID 41056581›Full record

Trial reportGynecologic oncology2025

Patient-reported outcomes of a randomized phase III clinical trial of adjuvant radiation versus chemoradiation in intermediate risk, stage I/IIA cervical cancer patients treated with initial radical hysterectomy and pelvic lymphadenectomy (NRG/GOG-0263).

Dana M Chase, Helen Q Huang, Wei Deng, Wui-Jin Koh, William Rodgers, William Small, Kevin Albuquerque, Jyoti Mayadev, Charles A Leath, Bradley Monk and 12 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Gynecologic oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–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

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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

22 authors.

Dana M ChaseDivision of Gynecologic Oncology, David Geffen School of Medicine UCLA, Los Angeles, CA, USA. Electronic address: dmchase@mednet.ucla.edu.
Helen Q HuangNRG Oncology Statistics and Data Management Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: huangh@nrgoncology.org.
Wei DengNRG Oncology Statistics and Data Management Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: dengw@nrgoncology.org.
Wui-Jin KohNational Comprehensive Cancer Network, Plymouth Meeting, PA, USA. Electronic address: koh@nccn.org.
William RodgersDepartment of Radiation Oncology, Weill Cornell Medicine, New York, NY, USA. Electronic address: whr9001@med.cornell.edu.
William SmallDepartment of Radiation Oncology, Stritch School of Medicine, Cardinal Bernadin Cancer Center, Loyola University Chicago, Maywood, IL, USA. Electronic address: wmsmall@lumc.edu.
Kevin AlbuquerqueDepartment of Radiation Oncology, UT Southwestern Medical Center, Dallas, TX, USA. Electronic address: Kevin.Albuquerque@utsouthwestern.edu.
Jyoti MayadevDepartment of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, CA, USA. Electronic address: jmayadev@health.ucsd.edu.
Charles A LeathDivision of Gynecologic Oncology, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: cleath@uabmc.edu.
Bradley MonkDepartment of Obstetrics and Gynecology, Creighton University School of Medicine at St. Joseph's Hospital and Medical Center, Phoenix, AZ, USA.
Beob-Jong KimDepartment of Gynecologic Oncology, Korean Cancer Center Hospital, Seoul, South Korea. Electronic address: beob@kcch.re.kr.
Dae-Yeon KimDepartment of Obstetrics and Gynecology, Asan Medical Center, Seoul, South Korea. Electronic address: kdyog@amc.seoul.kr.
Chi Heum ChoDepartment of Obstetrics and Gynecology, Keimyung University Dongsan Medical Center, Daegu, South Korea. Electronic address: c0035@dsmc.or.kr.
Jae-Weon KimDepartment of Obstetrics and Gynecology, Seoul National University Hospital, Seoul, South Korea. Electronic address: kjwksh@snu.ac.kr.
Jae Hong NoDepartment of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam, South Korea. Electronic address: 65561@snubh.org.
Laura HolmanDivision of Gynecologic Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. Electronic address: holman@ouhsc.edu.
Ashley StuckeyDepartment of Obstetrics and Gynecology, Women and Infants Hospital, Providence, RI, USA. Electronic address: astuckey@wihri.org.
Denise FabianDepartment of Radiation Oncology, University of Kentucky, Lexington, KY, USA. Electronic address: denise.fabian@uky.edu.
Alexandra H SmickDivision of Gynecologic Oncology, David Geffen School of Medicine UCLA, Los Angeles, CA, USA.
Lari WenzelDepartment of Population Health and Disease Prevention, University of California, Irvine, CA, USA. Electronic address: lwenzel@uci.edu.
Karen GilDepartment of Obstetrics and Gynecology, Northeast Ohio Medical University, Rootstown, OH, USA. Electronic address: kmg1@neomed.edu.
Sang Young RyuDepartment of Radiation Oncology, Korea Institute of Radiological and Medical Sciences, Seoul, South Korea. Electronic address: ryu@kirams.re.kr.

Funding

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 James J. Dignam, GREG YOTHERS · 2014 to 2026
$146.4M
Univ.of Calif., Irvine Cancer Center Support GrantP30CA062203 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI Melanie Funes · 1994 to 2026
$57.9M
Treatment of HIV- and HIV+ Patients with HPV16+ CIN2/3 Using pNGLV4a-hCRTE6E7L2 DNA vaccine administered intramuscularly via electroporationP50CA098252 · NCI · JOHNS HOPKINS UNIVERSITY · PI TZYY-CHOOU WU · 2003 to 2026
$53.5M
NCI NIH HHS P30 CA062203NCI NIH HHS P50 CA098252NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868
6 · The paper itself

Abstract

objectiveTo prospectively evaluate the impact of adjuvant chemoradiation (RT + CIS) versus radiation (RT) on quality of life (QOL) and patient-reported outcomes (PROs) among patients with intermediate-risk, stage I-IIA cervical cancer treated with radical hysterectomy and pelvic lymphadenectomy.

methodsPatients enrolled in GOG-0263 completed PRO/QOL assessments at baseline, 3, 7, and 36 weeks using the FACT-Cx Trial Outcome Index (FACT-Cx TOI), FACT/GOG-Neurotoxicity subscale (FACT/GOG-Ntx-4), the worst pain item from the Brief Pain Inventory (BPI), and five gastrointestinal/genitourinary (GI/GU) symptom items. Linear mixed models adjusted for baseline score, treatment, age, performance status, and country.

resultsAmong 316 randomized eligible patients (RT + CIS: n = 158; RT: n = 158), questionnaire completion rates were 98 %, 90 %, 88 %, and 81 % at baseline, weeks 3, 7, and 36, respectively. Patients receiving RT + CIS reported a mean FACT-Cx TOI score 5.1 points lower than RT at 3 weeks (97.5 % CI: -8.6 to -1.6; p = 0.004) and 6.3 points lower at 7 weeks (97.5 % CI: -10.2 to -2.4; p = 0.002). By 36 weeks, scores had returned to baseline in both groups, with no significant difference (p = 0.386). Patient-reported neuropathy scores (FACT/GOG-Ntx-4) did not differ significantly between groups at any time point (p = 0.82). Patient-reported GI/GU symptoms and pain worsened at 3 weeks in both arms, followed by recovery to baseline by 36 weeks.

conclusionQOL declined in both groups after treatment initiation, with greater short-term deterioration in the RT + CIS group. By 36 weeks, QOL and other PROs returned to baseline in both groups. Neuropathy, GI/GU symptoms, and pain showed no significant differences between treatment arms over time.

Indexed as

Uterine Cervical NeoplasmsAdultAgedChemoradiotherapy, AdjuvantFemaleHumansHysterectomyLymph Node ExcisionMiddle AgedNeoplasm StagingPatient Reported Outcome MeasuresProspective StudiesQuality of LifeRadiotherapy, AdjuvantAdjuvant therapyCervical cancerChemoradiotherapyPatient-reported outcomesQuality of life

Identifiers

PMID41056581
PMCPMC12767459

What OpenQuestion holds

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Registered trials

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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.