Evidence map›Paper›PMID 33545254›Full record

ArticleRadiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology2021

Risk factors and dose-effects for bladder fistula, bleeding and cystitis after radiotherapy with imaged-guided adaptive brachytherapy for cervical cancer: An EMBRACE analysis.

Sofia Spampinato, Lars U Fokdal, Richard Pötter, Christine Haie-Meder, Jacob C Lindegaard, Maximilian P Schmid, Alina Sturdza, Ina M Jürgenliemk-Schulz, Umesh Mahantshetty, Barbara Segedin and 15 more

Registry-linked trialAbstract read
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In one paragraph

Article in Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07164534 (A Phase III Trial to Assess the Effectiveness of NRF2 Activator), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing 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.

NCT07164534 phase3not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Phase III Trial to Assess the Effectiveness of NRF2 Activator (Oral Sodium-copper- Chlophyllin ) in Locally Advanced Cervical Cancer to Reduce Late Radiotherapy Toxicity. (CHOC-LATE Trial)

TypeinterventionalSponsorTata Memorial HospitalRan2026 to 2030Enrolled316ConditionsUterine Cervical NeoplasmArmsSodium-copper-chlorophyllin, a semi-synthetic derivative of chlorophyll, is made up of a mixture of sodium copper salts.
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. The impact of uterine position during brachytherapy on treatment outcomes and toxicity in patients with cervical cancer.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2026
    Article
  4. Article
  5. Surgical interventions for treating vesicovaginal fistula in women.The Cochrane database of systematic reviews · 2026
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Adaptive brachytherapy for cervical cancer in combined 1.5 T MR/HDR suite: Impact of repeated imaging.Technical innovations & patient support in radiation oncology · 2024
    Article
  14. Review
  15. Article
  16. ESGO/ESTRO quality indicators for radiation therapy of cervical cancer.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2023
    Article
  17. Article
  18. Electronic brachytherapy for gynecological cancers - a systematic review.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2023
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors.

Sofia SpampinatoDepartment of Oncology, Aarhus University Hospital, Denmark. Electronic address: sofspa@rm.dk.
Lars U FokdalDepartment of Oncology, Aarhus University Hospital, Denmark.
Richard PötterDepartment of Radiation Oncology, Comprehensive Cancer Center, Medical University of Vienna, Austria.
Christine Haie-MederDepartment of Radiotherapy, Gustave-Roussy, Villejuif, France.
Jacob C LindegaardDepartment of Oncology, Aarhus University Hospital, Denmark.
Maximilian P SchmidDepartment of Radiation Oncology, Comprehensive Cancer Center, Medical University of Vienna, Austria.
Alina SturdzaDepartment of Radiation Oncology, Comprehensive Cancer Center, Medical University of Vienna, Austria.
Ina M Jürgenliemk-SchulzDepartment of Radiation Oncology, University Medical Centre Utrecht, The Netherlands.
Umesh MahantshettyDepartment of Radiation Oncology, Tata Memorial Hospital, Mumbai, India.
Barbara SegedinDepartment of Radiotherapy, Institute of Oncology Ljubljana, Slovenia.
Kjersti BruheimDepartment of Oncology, The Norwegian Radium Hospital - Oslo University Hospital, Norway.
Peter HoskinMount Vernon Cancer Centre, Mount Vernon Hospital, Northwood, United Kingdom.
Bhavana RaiDepartment of Radiotherapy and Oncology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Fleur HuangDepartment of Oncology, Cross Cancer Institute and University of Alberta, Edmonton, Canada.
Rachel CooperLeeds Cancer Centre, St James's University Hospital, United Kingdom.
Elzbieta van der Steen-BanasikDepartment of Radiotherapy, Radiotherapiegroep Arnhem, The Netherlands.
Erik Van LimbergenDepartment of Radiation Oncology, UZ Leuven, Leuven, Belgium.
Marit SundsetClinic of Oncology and Women's Clinic, St. Olavs Hospital, Trondheim, Norway.
Henrike WesterveldDepartment of Radiation Oncology, Amsterdam University Medical Centers, University of Amsterdam, The Netherlands.
Remi A NoutDepartment of Radiation Oncology, Leiden University Medical Center, The Netherlands.
Nina B K JensenDepartment of Oncology, Aarhus University Hospital, Denmark.
Christian KirisitsDepartment of Radiation Oncology, Comprehensive Cancer Center, Medical University of Vienna, Austria.
Kathrin KirchheinerDepartment of Radiation Oncology, Comprehensive Cancer Center, Medical University of Vienna, Austria.
Kari TanderupDepartment of Oncology, Aarhus University Hospital, Denmark.
EMBRACE Collaborative Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo identify patient- and treatment-related risk factors for fistula, bleeding, cystitis, pain and difficulty in voiding in locally advanced cervical cancer patients treated with radio(chemo)therapy and image-guided adaptive brachytherapy (IGABT). MATERIAL AND

methodsMorbidity within the EMBRACE-I study was prospectively reported for physician-assessed (CTCAE) fistula, bleeding and cystitis and patient-reported (EORTC) pain and difficulty in voiding. Analysis of risk factors was performed in patients without bladder infiltration. Risk factors were tested with Cox regression for grade (G) ≥ 3 cystitis, for G ≥ 2 fistula, bleeding and cystitis, and for EORTC "very much" and "quite a bit" or worse.

resultsOf 1416 patients enrolled, 1153 and 884 patients without bladder infiltration were evaluable for the analysis of CTCAE and EORTC items, respectively. Median follow-up was 48[3-120] months. Crude incidence rates for G ≥ 2 fistula, bleeding and cystitis were 0.7%, 2.7% and 8.8%, respectively, and 16% and 14% for "quite a bit" or worse pain and difficulty in voiding, respectively. Baseline urinary morbidity and overweight/obesity were significant risk factors for most endpoints. Bladder D

conclusionClinical and treatment-related risk factors for bladder fistula, bleeding and cystitis were identified within a prospective and multi-institutional setting. A dose-effect was established with bladder D

Indexed as

BrachytherapyCystitisRadiotherapy, Image-GuidedUterine Cervical NeoplasmsChemoradiotherapyFemaleHumansProspective StudiesRadiotherapy DosageRisk FactorsCervical cancerClinical studyDose-effect relationshipIGABTRisk factorsUrinary morbidity

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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.