Evidence map›Paper›PMID 25847373›Full record

Trial reportCancer2015

NRG Oncology/RTOG 0921: A phase 2 study of postoperative intensity-modulated radiotherapy with concurrent cisplatin and bevacizumab followed by carboplatin and paclitaxel for patients with endometrial cancer.

Akila N Viswanathan, Jennifer Moughan, Brigitte E Miller, Ying Xiao, Anuja Jhingran, Lorraine Portelance, Walter R Bosch, Ursula A Matulonis, Neil S Horowitz, Robert S Mannel and 5 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
3.1field-weighted citation impact, top 9% 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.

NCT01005329 phase2completednot on this map

A Phase II Study of Postoperative Intensity Modulated Radiation Therapy (IMRT) With Concurrent Cisplatin and Bevacizumab Followed by Carboplatin and Paclitaxel for Patients With Endometrial Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2009 to 2013Enrolled34ConditionsEndometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous AdenocarcinomaArmsBevacizumab, Carboplatin, Cisplatin, Intensity-Modulated Radiation Therapy, Paclitaxel
NCT03935256 phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

Phase II Study of Concurrent and Sequential Carboplatin and Paclitaxel With Adjuvant Radiotherapy for High Risk Endometrial Cancer

TypeinterventionalSponsorLoyola UniversityRan2019 to 2024Enrolled24ConditionsEndometrial CancerArmsCarboplatin and Paclitaxel, Radiation Therapy
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 48 citations in OpenAlex.

  1. Article
  2. Review
  3. Radiation therapy for vulvar cancer: consensus technical guidelines of the GINECOR working group of the Spanish Society of Radiation Oncology. Part 2: radiotherapy recommendations.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
    Article
  4. Review
  5. Article
  6. Construction of a predictive model for radiation proctitis after radiotherapy for female pelvic tumors based on machine learning.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2022
    Article
  7. Article
  8. Review
  9. Sequencing chemotherapy before radiotherapy for women with stage IIIC endometrial cancer.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2021
    Article
  10. Article
  11. Article
  12. Is one brachytherapy fraction of 7 Gy similar to more fractions after external beam irradiation in postoperative endometrial carcinoma?Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
    Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

15 authors at 13 institutions in 2 countries.

Akila N ViswanathanDepartment of Radiation Oncology, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.
Jennifer MoughanNRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
Brigitte E MillerCarolinas Healthcare System NorthEast, Levine Cancer Institute, Concord, North Carolina.
Ying XiaoThomas Jefferson University Hospital, Philadelphia, Pennsylvania.
Anuja JhingranThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Lorraine PortelanceUniversity of Miami Miller School of Medicine, Miami, Florida.
Walter R BoschWashington University, St. Louis, Missouri.
Ursula A MatulonisDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Neil S HorowitzDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, MA.
Robert S MannelUniversity of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.
Luis SouhamiMcGill University, Montreal, Quebec, Canada.
Beth A EricksonMedical College of Wisconsin, Milwaukee, Wisconsin.
Kathryn A WinterNRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
William SmallLoyola University, Chicago, Illinois.
David K GaffneyUniversity of Utah Health Science Center, Salt Lake City, Utah.
Dana-Farber Cancer Institute · USNRG Oncology · USBrigham and Women's Hospital · USLevine Cancer Institute · USLoyola University Chicago · USMcGill University · CAMedical College of Wisconsin · USThe University of Texas MD Anderson Cancer Center · USThomas Jefferson University Hospital · USUniversity of Miami · USUniversity of Oklahoma Health Sciences Center · USUtah Department of Health · USWashington University in St. Louis · 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
RTOG Foreign AccrualU10CA021661 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI CURRAN, WALTER J. · 1985 to 2013
$150.3M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam · 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
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
RTOG Foreign AccrualsU10CA037422 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI BRUNER, DEBORAH WATKINS · 1985 to 2013
$30.4M
ADVANCED TECHNOLOGY QA CENTERU24CA081647 · NCI · WASHINGTON UNIVERSITY · PI MICHALSKI, JEFF M. · 1999 to 2013
$22.8M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareUG1CA233180 · NCI · DANA-FARBER CANCER INST · PI Harold John Burstein · 2019 to 2026
$8.6M
Lead Academic Participating Site for the Development and Conduct of NCTN TrialsU10CA180798 · NCI · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI MANNEL, ROBERT S., MOORE, KATHLEEN N. · 2014 to 2018
$6.7M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareU10CA180867 · NCI · DANA-FARBER CANCER INST · PI BURSTEIN, HAROLD JOHN, KIBEL, ADAM S · 2014 to 2018
$6.2M
Huntsman Cancer Institute/ University of Utah Network Lead Academic Participating Site ApplicationUG1CA233178 · NCI · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI Matthew Poppe, Heloisa Prado Soares · 2019 to 2026
$4.9M
Huntsman Cancer Institute/Univ of Utah Network Lead Academic Participating SiteU10CA180818 · NCI · UNIVERSITY OF UTAH · PI GAFFNEY, DAVID K · 2014 to 2018
$3.2M
NCI NIH HHS R21 CA167800NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA037422NCI NIH HHS U10 CA180798NCI NIH HHS U10 CA180818NCI NIH HHS U10 CA180822NCI NIH HHS U10CA180822NCI NIH HHS U10 CA180867NCI NIH HHS U10 CA180868NCI NIH HHS U10CA180868NCI NIH HHS U10CA21661NCI NIH HHS U10CA37422NCI NIH HHS U24 CA081647NCI NIH HHS U24 CA180803NCI NIH HHS U24CA180803NCI NIH HHS U24CA81647NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA233178NCI NIH HHS UG1 CA233180
6 · The paper itself

Abstract

backgroundThe current study was conducted to assess acute and late adverse events (AEs), overall survival (OS), pelvic failure, regional failure, distant failure, and disease-free survival in a prospective phase 2 clinical trial of bevacizumab and pelvic intensity-modulated radiotherapy (IMRT) with chemotherapy in patients with high-risk endometrial cancer.

methodsPatients underwent a hysterectomy and lymph node removal, and had ≥1 of the following high-risk factors: grade 3 carcinoma with >50% myometrial invasion, grade 2 or 3 disease with any cervical stromal invasion, or known extrauterine extension confined to the pelvis. Treatment included pelvic IMRT and concurrent cisplatin on days 1 and 29 of radiation and bevacizumab (at a dose of 5 mg/kg on days 1, 15, and 29 of radiation) followed by adjuvant carboplatin and paclitaxel for 4 cycles. The primary endpoint was grade ≥3 AEs occurring within the first 90 days (toxicity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]).

resultsA total of 34 patients were accrued from November 2009 through December 2011, 30 of whom were eligible and received study treatment. Seven of 30 patients (23.3%; 1-sided 95% confidence interval, 10.6%-36.0%) developed grade ≥3 treatment-related nonhematologic toxicities within 90 days; an additional 6 patients experienced grade ≥3 toxicities between 90 and 365 days after treatment. The 2-year OS rate was 96.7% and the disease-free survival rate was 79.1%. No patient developed a within-field pelvic failure and no patients with International Federation of Gynecology and Obstetrics stage I to IIIA disease developed disease recurrence after a median follow-up of 26 months.

conclusionsPostoperative bevacizumab added to chemotherapy and pelvic IMRT appears to be well tolerated and results in high OS rates at 2 years for patients with high-risk endometrial carcinoma.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBevacizumabChemoradiotherapy, AdjuvantCisplatinDisease-Free SurvivalEndometrial NeoplasmsFemaleHumansHysterectomyLymph Node ExcisionMiddle AgedPaclitaxelPostoperative PeriodBevacizumabCisplatinPaclitaxelbevacizumabchemotherapyendometrial cancerintensity-modulated radiotherapy (IMRT)radiation

Identifiers

PMID25847373
PMCPMC4685031
OpenAlexW1529678579

What OpenQuestion holds

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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.