Evidence map›Paper›PMID 26780997›Full record

ArticleRadiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology2016

Dose-effect relationship and risk factors for vaginal stenosis after definitive radio(chemo)therapy with image-guided brachytherapy for locally advanced cervical cancer in the EMBRACE study.

Kathrin Kirchheiner, Remi A Nout, Jacob C Lindegaard, Christine Haie-Meder, Umesh Mahantshetty, Barbara Segedin, Ina M Jürgenliemk-Schulz, Peter J Hoskin, Bhavana Rai, Wolfgang Dörr and 5 more

4 registry-linked trialsAbstract read
PubMed Publisher
In one paragraph

Article in Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 70 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 4 pooled it
22.5field-weighted citation impact, top 1% 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.

NCT03090217 naunknown statusnot on this mapstarted 2017, after this paper: background citation

Pelvic Physiotherapy in the Prevention of Vaginal Stenosis Secondary to Radiotherapy of Gynecological Cancer: a Randomized Controlled Trial

TypeinterventionalSponsorFederal University of Health Science of Porto AlegreRan2017 to 2018Enrolled160ConditionsGynecologic Cancer, Pathological ConstrictionArmsPelvic Physiotherapy, Standard care (SC)
NCT03257475 unknown statusnot on this mapstarted 2017, after this paper: background citation

Evaluation of Vaginal Dose in Cervical Cancer Patients Treated With Radiotherapy

TypeobservationalSponsorXi'an Jiaotong UniversityRan2017 to 2019Enrolled500ConditionsCervical CancerArmsBrachytherapy
NCT03876860 naunknown statusnot on this mapstarted 2018, after this paper: background citation

An Enhanced Vaginal Dilator Model to Improve Patient Adherence and Reduce Radiation-Induced Vaginal Stenosis: a Randomized Control Trial

TypeinterventionalSponsorMargaret LiottaRan2018 to 2024Enrolled118ConditionsEndometrial Cancer, Cervical Cancer, Vaginal Stricture, Radiation ToxicityArmsSilicone Dilator, Standard Dilator
NCT04184154 completednot on this mapstarted 2017, after this paper: background citation

Vaginal Dilatators and Moisturizers Use and Sexual Quality of Life of Patients With Gynecologic Cancer Treated With Brachytherapy.

TypeobservationalSponsorInstitut du Cancer de Montpellier - Val d'AurelleRan2017 to 2017Enrolled167ConditionsPelvic Cancer, Cervical CancerArmsQuestionnaires
3 · Its place in the literature

Who cites it

70 citing papers in PubMed, 4 syntheses or guidelines pooled it, 208 citations in OpenAlex.

  1. Let's talk about sex: consensus guidelines of the GINECOR working group of the Spanish Society of Radiation Oncology: clinical recommendations after pelvic radiotherapy.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
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  15. HPV-driven cancer: from epidemiology to the HPV-driven tumor board proposal, everything you wanted to know but were afraid to ask.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Review
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  20. Impact of Vaginal Dilator Use and 68 Gy EQD2Journal of personalized medicine · 2024
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10 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 8 countries.

Kathrin KirchheinerDepartment of Radiation Oncology, Comprehensive Cancer Center, Medical University of Vienna/General Hospital of Vienna, Austria. Electronic address: kathrin.kirchheiner@meduniwien.ac.at.
Remi A NoutDepartment of Radiation Oncology, Leiden University Medical Center, The Netherlands.
Jacob C LindegaardDepartment of Oncology, Aarhus University Hospital, Denmark.
Christine Haie-MederDepartment of Radiotherapy, Gustave-Roussy, Villejuif, France.
Umesh MahantshettyDepartment of Radiation Oncology, Tata Memorial Hospital, Mumbai, India.
Barbara SegedinDepartment of Radiotherapy, Institute of Oncology, Ljubljana, Slovenia.
Ina M Jürgenliemk-SchulzDepartment of Radiation Oncology, University Medical Centre, Utrecht, The Netherlands.
Peter J HoskinCancer Centre, Mount Vernon Hospital, London, UK.
Bhavana RaiDepartment of Radiotherapy and Oncology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Wolfgang DörrDepartment of Radiation Oncology, Comprehensive Cancer Center, Medical University of Vienna/General Hospital of Vienna, Austria; Christian Doppler Laboratory for Medical Radiation Research for Radiation Oncology, Medical University of Vienna, Austria.
Christian KirisitsDepartment of Radiation Oncology, Comprehensive Cancer Center, Medical University of Vienna/General Hospital of Vienna, Austria.
Søren M BentzenDepartment of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, USA.
Richard PötterDepartment of Radiation Oncology, Comprehensive Cancer Center, Medical University of Vienna/General Hospital of Vienna, Austria; Christian Doppler Laboratory for Medical Radiation Research for Radiation Oncology, Medical University of Vienna, Austria.
Kari TanderupDepartment of Oncology, Aarhus University Hospital, Denmark.
EMBRACE Collaborative Group
Vienna General Hospital · ATAarhus University Hospital · DKInstitute of Oncology Ljubljana · SIInstitut Gustave Roussy · FRLeiden University Medical Center · NLMedical University of Vienna · ATMount Vernon Hospital · GBPost Graduate Institute of Medical Education and Research · INTata Memorial Hospital · INUniversity Medical Center Utrecht · NLUniversity of Maryland, Baltimore · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background/purposeTo identify risk factors for vaginal stenosis and to establish a dose-effect relationship for image-guided brachytherapy in locally advanced cervical cancer. MATERIALS/

methodsPatients from the ongoing EMBRACE study with prospectively assessed morbidity (CTCAEv3.0) at baseline and at least one follow-up were selected. Patient-, disease- and treatment characteristics were tested as risk factors for vaginal stenosis G ⩾ 2 in univariate and multivariable analyses (Cox proportional hazards model) and a dose-effect curve was deduced from the estimates. The ICRU rectum point was used to derive the recto-vaginal reference point dose.

resultsIn 630 patients included (median follow-up 24months), 2-year actuarial estimate for vaginal stenosis G ⩾ 2 was 21%. Recto-vaginal reference point dose (HR=1.025, p=0.029), external beam radiotherapy (EBRT) dose >45 Gy/25 fractions (HR=1.770, p=0.056) and tumor extension in the vagina (HR=2.259, p ⩽ 0.001) were risk factors for vaginal stenosis, adjusted for center reporting effects. Based on the model curve, the risk was 20% at 65 Gy, 27% at 75 Gy and 34% at 85 Gy (recto-vaginal reference point dose).

conclusionKeeping the EBRT dose at 45 Gy/25 fractions and decreasing the dose contribution of brachytherapy to the vagina decrease the risk of stenosis. A planning aim of ⩽65 Gy EQD2 (EBRT+brachytherapy dose) to the recto-vaginal reference point is therefore proposed.

Indexed as

Radiotherapy, Image-GuidedAdultAgedAged, 80 and overBrachytherapyChemoradiotherapyConstriction, PathologicDose-Response Relationship, RadiationFemaleHumansMiddle AgedProportional Hazards ModelsProspective StudiesRadiation InjuriesRadiotherapy DosageRisk FactorsICRU recto-vaginal pointImage-guided brachytherapyRadiotherapyVaginal morbidityVaginal shortening/narrowing

Identifiers

PMID26780997
OpenAlexW2222645822

What OpenQuestion holds

Textmetadata
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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.