Evidence map›Paper›PMID 34903380›Full record

Trial reportGynecologic oncology2022

Patient reported outcomes for cisplatin and radiation followed by carboplatin/paclitaxel versus carboplatin/paclitaxel for locally advanced endometrial carcinoma: An NRG oncology study.

Ursula A Matulonis, Helen Q Huang, Virginia L Filiaci, Marcus Randall, Paul A DiSilvestro, Katherine M Moxley, Jeffrey M Fowler, Matthew A Powell, Nick M Spirtos, Krishnansu S Tewari and 6 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Gynecologic oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00942357 (A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 22% 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.

NCT00942357 phase3unknown statusnot on this map

A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma

TypeinterventionalSponsorGynecologic Oncology GroupRan2009 to 2024Enrolled813ConditionsEndometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Stage IA Uterine Corpus Cancer AJCC v7, Stage IB Uterine Corpus Cancer AJCC v7ArmsCarboplatin, Cisplatin, Internal Radiation Therapy, Paclitaxel, Quality-of-Life Assessment
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Can Cisplatin Therapy Be Improved? Pathways That Can Be Targeted.International journal of molecular sciences · 2022
    Review
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

16 authors at 14 institutions in 1 country.

Ursula A MatulonisDana-Farber Cancer Institute, Boston, MA, USA. Electronic address: Ursula_Matulonis@dfci.harvard.edu.
Helen Q HuangNRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: HuangH@NRGOncology.org.
Virginia L FiliaciNRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: FiliaciV@NRGOncology.org.
Marcus RandallUniversity of Kentucky, Department of Radiation Medicine, Lexington, KY, USA. Electronic address: merand2@uky.edu.
Paul A DiSilvestroWomen and Infants Hospital in Rhode Island/The Warren Alpert Medical School of Brown University, Providence, RI, USA. Electronic address: PDiSilvestro@Wihri.org.
Katherine M MoxleyStephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. Electronic address: kmoxley@med.umich.edu.
Jeffrey M FowlerOhio State University Comprehensive Cancer Center, Obstetrics and Gynecology, Hilliard, OH, USA. Electronic address: Jeffrey.Fowler@osumc.edu.
Matthew A PowellWashington University School of Medicine, Siteman Cancer Center, St. Louis, MO, USA. Electronic address: mpowell@wustl.edu.
Nick M SpirtosWomen's Cancer Center of Nevada, Las Vegas, NV, USA. Electronic address: nspirtos@wccenter.com.
Krishnansu S TewariUniversity of California Irvine Medical Center, Irvine, CA, USA. Electronic address: ktewari@uci.edu.
William E RichardsGeorgia Core, Gynecologic Oncology, St. Joseph's Candler Oncology, Savannah, GA, USA.
John M NakayamaUH Cleveland Medical Center. University Hospitals, Cleveland, OH, USA. Electronic address: john.nakayama@ahn.org.
David G MutchWashington University School of Medicine, Siteman Cancer Center, St. Louis, MO, USA. Electronic address: mutchd@wudosis.wustl.edu.
David S MillerUniversity of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: David.Miller@utsouthwestern.edu.
Daniela MateiNorthwestern University, Division of Gynecologic Oncology Chicago, IL, USA. Electronic address: Daniela.matei@northwestern.edu.
Lari B WenzelUniversity of California Irvine Medical Center, Irvine, CA, USA. Electronic address: lwenzel@uci.edu.
University of California, Irvine Medical Center · USWashington University in St. Louis · USDana-Farber Cancer Institute · USNorthwestern University · USNRG Oncology · USRoswell Park Comprehensive Cancer Center · USSt. Joseph’s Candler Hospital · USThe Ohio State University · USThe University of Texas Southwestern Medical Center · USUniversity Hospitals of Cleveland · USUniversity of Kentucky · USUniversity of Oklahoma Health Sciences Center · USWomen & Infants Hospital of Rhode Island · USWomen's Cancer Center of Nevada · US

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
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
University of Buffalo Clinical and Translational Science Institute - Supplement SchulyerUL1TR001412 · NCATS · STATE UNIVERSITY OF NEW YORK AT BUFFALO · PI MURPHY, TIMOTHY F · 2015 to 2024
$33.8M
Project 2: Combined personal neoantigen-targeting cancer vaccines with immune checkpoint blockade for ovarian cancerP50CA240243 · NCI · DANA-FARBER CANCER INST · PI CASTRO, CESAR M · 2020 to 2024
$11.5M
UT Southwestern NCI National Clinical Trials Network (NCTN) LAPS - Supplemental Funds YR4UG1CA233302 · NCI · UT SOUTHWESTERN MEDICAL CENTER · PI David Eric Gerber · 2019 to 2026
$6.4M
Network Lead Academic Participating Site Grant from the Roswell Park Cancer InstituteUG1CA233191 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI LELE, SHASHIKANT, LEVINE, ELLIS G · 2019 to 2025
$3.1M
NCATS NIH HHS UL1 TR001412NCI NIH HHS P50 CA240243NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA233191NCI NIH HHS UG1 CA233302
6 · The paper itself

Abstract

introductionChemotherapy plus radiation (Cis-RT + CP) did not demonstrate superiority in prolonging relapse-free survival compared to chemotherapy alone in patients with stage III or IVA endometrial carcinoma. The impact of treatment on quality of life (QOL), neurotoxicity (NTX) and psychometric properties of the gastrointestinal (GI) symptoms subscale during treatment and up to 1 year are described herein.

methodsQOL assessments were scheduled at baseline, 6 weeks (post completion of RT (Cis-RT + CP) or prior to cycle 3 (CP)), then 18 weeks (end of treatment) and 70 weeks (1 year after the end of treatment) after starting treatment. QOL instruments included the FACT-En TOI, FACT/GOG-neurotoxicity (Ntx) subscale (short), and the gastrointestinal (GI) symptoms subscale.

resultsAt the end of treatment, patients receiving Cis-RT + CP reported a statistically significant decreased QOL when compared to CP. The decline in QOL was reflected in physical well-being, functional well-being, and endometrial cancer specific concerns, but the minimally important differences (MID) were not considered clinically meaningful. Patients in both groups reported increased chemotherapy-induced Ntx symptoms with the CP group having worse scores and reaching peak symptoms at the time of chemotherapy completion. Patients on Cis-RT + CP reported statistically significantly worse GI symptoms after radiation therapy compared to patients on CP, this occurred across assessment intervals, though the MID was not meaningful. Psychometric evaluations indicated that the GI symptom scale is reliable, valid, and responsive to change.

conclusionsPROs indicate that the chemoradiotherapy group experienced worse HRQoL and GI toxicity compared to patients randomized to chemotherapy alone for locally advanced endometrial cancer though based on the MID, these were not clinically meaningful differences. The GI symptom subscale was a reliable and valid scale that has value for future trials.

trial registrationNCT00942357.

Indexed as

Chemoradiotherapy, AdjuvantChemotherapy, AdjuvantQuality of LifeCarboplatinCisplatinDisease-Free SurvivalEndometrial NeoplasmsFemaleFunctional StatusGastrointestinal DiseasesHumansNeoplasm StagingPaclitaxelPatient Reported Outcome MeasuresPeripheral Nervous System DiseasesCarboplatinCisplatinPaclitaxelChemotherapyCombined radiation therapyEndometrial cancerPatient reported outcomesQuality of life

Identifiers

PMID34903380
PMCPMC9019849
OpenAlexW4200112742

What OpenQuestion holds

Textmetadata
LicenceTDM
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.