Evidence map›Paper›PMID 32816842›Full record

Trial reportBMJ (Clinical research ed.)2020

Long term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial.

Jayant S Vaidya, Max Bulsara, Michael Baum, Frederik Wenz, Samuele Massarut, Steffi Pigorsch, Michael Alvarado, Michael Douek, Christobel Saunders, Henrik L Flyger and 29 more

3 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ (Clinical research ed.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 150 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
150citing papers in PubMed, 14 pooled it
14.8field-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.

NCT00983684 phase3completednot on this map

TARGIT: A Randomised Controlled Trial to Compare Targeted Intra-operative Radiotherapy With Conventional Post-operative Radiotherapy After Conservative Breast Surgery for Women With Early Stage Breast Cancer

TypeinterventionalSponsorUniversity College, LondonRan2000 to 2012Enrolled3,451ConditionsInvasive Breast Cancer, Breast CancerArmsIntrabeam, Post-operative radiotherapy
NCT02290782 naactive not recruitingnot on this map

TARGIT-C(Consolidation) Prospective Phase IV Study of Intraoperative Radiotherapy (IORT) in Patients With Small Breast Cancer

TypeinterventionalSponsorUniversitätsmedizin MannheimRan2014 to 2026Enrolled387ConditionsBreast CancerArmsIntraoperative radiotherapy (IORT)
NCT04789889 naterminatednot on this mapstarted 2021, after this paper: background citation

Comparison of Satisfaction With Conserved Breast, Postoperative Complications and Tumor Control Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery

TypeinterventionalSponsorXiangyun ZongRan2021 to 2025Enrolled80ConditionsQuality of LifeArmsintraoperative radiotherapy, postoperative radiotherapy
3 · Its place in the literature

Who cites it

150 citing papers in PubMed, 14 syntheses or guidelines pooled it, 283 citations in OpenAlex.

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  4. Prospects and Disadvantages of Intraoperative Radiotherapy: A Systematic Review.Asian Pacific journal of cancer prevention : APJCP · 2025
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90 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

39 authors at 20 institutions in 10 countries.

Jayant S VaidyaDivision of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK jayantvaidya@gmail.com.ORCID 0000-0003-1760-1278
Max BulsaraDepartment of Biostatistics, University of Notre Dame, Fremantle, WA, Australia.
Michael BaumDivision of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK.
Frederik WenzDepartment of Radiation Oncology, University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.
Samuele MassarutDepartment of Surgery, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.
Steffi PigorschDepartment of Gynaecology and Obstetrics, Red Cross Hospital, Technical University of Munich, Munich, Germany.
Michael AlvaradoDepartment of Surgery, University of California, San Francisco, CA, USA.
Michael DouekNuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
Christobel SaundersSchool of Surgery, University of Western Australia, Crawley, WA, Australia.
Henrik L FlygerDepartment of Breast Surgery, University of Copenhagen, Copenhagen, Denmark.
Wolfgang EiermannDepartment of Gynaecology and Obstetrics, Red Cross Hospital, Technical University of Munich, Munich, Germany.
Chris Brew-GravesDivision of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK.
Norman R WilliamsDivision of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK.
Ingrid PotykaDivision of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK.
Nicholas RobertsDivision of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK.
Marcelle BernsteinLondon, UK.
Douglas BrownDepartment of Surgery, Ninewells Hospital, Dundee, UK.
Elena SperkDepartment of Radiation Oncology, University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.
Siobhan LawsDepartment of Surgery, Royal Hampshire County Hospital, Winchester, UK.
Marc SütterlinDepartment of Gynaecology and Obstetrics, University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.
Tammy CoricaDepartment of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.
Steinar LundgrenDepartment of Oncology, St Olav's University Hospital, Trondheim, Norway.
Dennis HolmesUniversity of Southern California, John Wayne Cancer Institute & Helen Rey Breast Cancer Foundation, Los Angeles, CA, USA.
Lorenzo VinanteDepartment of Radiation Oncology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.
Fernando BozzaInstituto Oncologico Veneto, Padoa, Italy.
Montserrat PazosDepartment of Radiation Oncology, University Hospital, The Ludwig Maximilian University of Munich, Munich, Germany.
Magali Le Blanc-OnfroyRadiotherapy-Oncology, Western Cancer Institute, Nantes, France.
Günther GruberBreast Centre Seefeld, Zurich, Switzerland.
Wojciech PolkowskiDepartment of Surgical Oncology, Medical University of Lublin, Lublin, Poland.
Konstantin J DedesBreast Centre, University Hospital Zurich, Zurich, Switzerland.
Marcus NiewaldSaarland University Medical Center, Homberg, Germany.
Jens BlohmerSankt Gertrauden Hospital, Charité, Medical University of Berlin, Berlin, Germany.
David McCreadyPrincess Margaret Cancer Centre, Toronto, Ontario, Canada.
Richard HoeferSentara Surgery Specialists, Hampton, VA, USA.
Pond KelemenAshikari Breast Center, New York Medical College, New York, NY, USA.
Gloria PetraliaDepartment of Surgery, University College London Hospitals, London, UK.
Mary FalzonDepartment of Pathology, University College London Hospitals, London, UK.
David J JosephDepartment of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.
Jeffrey S Tobias
University College London · GBHeidelberg University · DECentro di Riferimento Oncologico · ITKrankenhaus vom Roten Kreuz · DERoyal London Hospital · GBSir Charles Gairdner Hospital · AUBreast Center · CHFon (United Kingdom) · GBIstituto Oncologico Veneto · ITLudwig-Maximilians-Universität München · DEMedical University of Lublin · PLNew York Medical College · USNinewells Hospital · GBNorwegian University of Science and Technology · NOPrincess Margaret Cancer Centre · CARoyal Hampshire County Hospital · GBSaarland University · DESankt Gertrauden Krankenhaus · DEThe University of Notre Dame Australia · AUThe University of Western Australia · AU

Funding

Department of Health 07/60/49Department of Health 10/104/07Department of Health 14/49/13Department of Health HTA/14/49/13
6 · The paper itself

Abstract

objectiveTo determine whether risk adapted intraoperative radiotherapy, delivered as a single dose during lumpectomy, can effectively replace postoperative whole breast external beam radiotherapy for early breast cancer.

designProspective, open label, randomised controlled clinical trial.

setting32 centres in 10 countries in the United Kingdom, Europe, Australia, the United States, and Canada.

participants2298 women aged 45 years and older with invasive ductal carcinoma up to 3.5 cm in size, cN0-N1, eligible for breast conservation and randomised before lumpectomy (1:1 ratio, blocks stratified by centre) to either risk adapted targeted intraoperative radiotherapy (TARGIT-IORT) or external beam radiotherapy (EBRT).

interventionsRandom allocation was to the EBRT arm, which consisted of a standard daily fractionated course (three to six weeks) of whole breast radiotherapy, or the TARGIT-IORT arm. TARGIT-IORT was given immediately after lumpectomy under the same anaesthetic and was the only radiotherapy for most patients (around 80%). TARGIT-IORT was supplemented by EBRT when postoperative histopathology found unsuspected higher risk factors (around 20% of patients).

main outcome measuresNon-inferiority with a margin of 2.5% for the absolute difference between the five year local recurrence rates of the two arms, and long term survival outcomes.

resultsBetween 24 March 2000 and 25 June 2012, 1140 patients were randomised to TARGIT-IORT and 1158 to EBRT. TARGIT-IORT was non-inferior to EBRT: the local recurrence risk at five year complete follow-up was 2.11% for TARGIT-IORT compared with 0.95% for EBRT (difference 1.16%, 90% confidence interval 0.32 to 1.99). In the first five years, 13 additional local recurrences were reported (24/1140

conclusionFor patients with early breast cancer who met our trial selection criteria, risk adapted immediate single dose TARGIT-IORT during lumpectomy was an effective alternative to EBRT, with comparable long term efficacy for cancer control and lower non-breast cancer mortality. TARGIT-IORT should be discussed with eligible patients when breast conserving surgery is planned.

trial registrationISRCTN34086741, NCT00983684.

Indexed as

AgedBreast NeoplasmsCarcinoma, Ductal, BreastCombined Modality TherapyFemaleHumansIntraoperative CareMastectomy, SegmentalMiddle AgedNeoplasm InvasivenessNeoplasm Recurrence, LocalProspective StudiesRadiotherapy DosageSurvival Rate

Identifiers

PMID32816842
PMCPMC7500441
OpenAlexW3067502370

What OpenQuestion holds

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LicenceCC BY
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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.