Evidence map›Paper›PMID 35934006›Full record

Trial reportLancet (London, England)2022

Radiation doses and fractionation schedules in non-low-risk ductal carcinoma in situ in the breast (BIG 3-07/TROG 07.01): a randomised, factorial, multicentre, open-label, phase 3 study.

Boon H Chua, Emma K Link, Ian H Kunkler, Timothy J Whelan, A Helen Westenberg, Guenther Gruber, Guy Bryant, Verity Ahern, Kash Purohit, Peter H Graham and 14 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2022. 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 49 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 4 pooled it
9.6field-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.

NCT00470236 naunknown statusnot on this map

A Randomised Phase III Study of Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast

TypeinterventionalSponsorTrans Tasman Radiation Oncology GroupRan2007 to 2024Enrolled1,608ConditionsCarcinoma, Ductal, BreastArmsStandard WB fractionation, Shorter WB fractionation, Standard WB fractionation+Boost, Shorter WB fractionation + Boost
NCT07020780 narecruitingnot on this mapstarted 2025, after this paper: background citation

Five Fractions Ultrahypofractionated Whole Breast Radiotherapy and Simultaneous Integrated Boost to the Tumor Bed, for Breast Cancer Patients With Unfavorable Characteristics

TypeinterventionalSponsorIRCCS San RaffaeleRan2025 to 2035Enrolled458ConditionsBreast CancerArmsAdjuvant 5 fractions whole breast irradiation with simultaneous integrated boost to the tumor bed
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 4 syntheses or guidelines pooled it, 103 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Trial
  6. A novel, multi-active emollient for the prevention of acute radiation dermatitis in breast cancer patients: a randomized clinical trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Trial
  7. Review
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  11. Article
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  14. Sustainability in radiation oncology: opportunities for enhancing patient care and reducing COStrahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2025
    Article
  15. Article
  16. Review
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  19. Hypofractionated whole and partial breast irradiation: Brazilian Society of Radiotherapy (SBRT) consensus.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2025
    Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 20 institutions in 8 countries.

Boon H ChuaFaculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia; Nelune Comprehensive Cancer Centre, Prince of Wales Hospital, Randwick, NSW, Australia. Electronic address: boon.chua@health.nsw.gov.au.
Emma K LinkPeter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, VIC, Australia.
Ian H KunklerEdinburgh Cancer Research Centre, Institute of Genetic and Molecular Medicine, University of Edinburgh, Western General Hospital, Edinburgh, UK.
Timothy J WhelanMcMaster University, Department of Oncology, Hamilton, ON, Canada; Juravinski Cancer Centre, Hamilton, ON, Canada.
A Helen WestenbergRadiotherapiegroep Arnhem, Arnhem, Netherlands.
Guenther GruberInstitute for Radiotherapy, Klinik Hirslanden, Zurich, Switzerland.
Guy BryantUniversity of Queensland, Brisbane, QLD, Australia.
Verity AhernUniversity of Sydney, Sydney, NSW, Australia; Westmead Hospital, Westmead, NSW, Australia.
Kash PurohitUniversity of Sheffield, Sheffield, UK; Weston Park Hospital, Broomhall, Sheffield, UK.
Peter H GrahamFaculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia; St George Hospital, Kogarah, NSW, Australia.
Mohamed AkraUniversity of Manitoba, Winnipeg, MB, Canada; Cancer Care Manitoba, Winnipeg, MB, Canada.
Orla McArdleCancer Trials Ireland, Dublin, Ireland; St Luke's Radiation Oncology Network, Beaumont Hospital, Beaumont, Dublin, Ireland.
Peter O'BrienUniversity of Newcastle, Newcastle, NSW, Australia; GenesisCare, Gateshead, NSW, Australia.
Jennifer A HarveyUniversity of Queensland, Brisbane, QLD, Australia; Princess Alexandra Hospital, Woolloongabba, QLD, Australia.
Carine KirkoveUniversité Catholique de Louvain, Brussels, Belgium; Cliniques Universitaires St Luc, Bruxelles, Belgium.
John H MaduroDepartment of Radiation Oncology, University Medical Centre Groningen, University of Groningen, Groningen, Netherlands.
Ian D CampbellUniversity of Auckland, Auckland, New Zealand; Waikato Hospital, Hamilton, New Zealand.
Geoff P DelaneyFaculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia; Liverpool Hospital, Liverpool, NSW, Australia.
Joseph D MartinNational University of Ireland, Galway, Ireland; University Hospital Galway, Galway, Ireland.
T Trinh T VuUniversité de Montréal, Montreal, QC, Canada; Centre hospitalier de l'Université de Montréal, Montreal, QC, Canada.
Thierry M MuanzaDepartment of Oncology, McGill University, Montreal, QC, Canada.
Anthony NealRoyal Surrey County Hospital, Guildford, UK.
Ivo A OlivottoUniversity of Calgary, Calgary, AB, Canada.
BIG 3–07/TROG 07.01 trial investigators
UNSW Sydney · AUBeaumont Hospital · IECentre Hospitalier de l’Université de Montréal · CACliniques Universitaires Saint-Luc · BEEdinburgh Cancer Research · GBKlinik Hirslanden · CHMcGill University · CAMcMaster University · CAPrincess Alexandra Hospital · AURadiotherapiegroep · NLRoyal Surrey County Hospital · GBSt George Hospital · AUThe University of Melbourne · AUThe University of Queensland · AUUniversity Hospital Galway · IEUniversity of Auckland · NZUniversity of Calgary · CAUniversity of Groningen · NLUniversity of Manitoba · CAUniversity of Newcastle Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhole breast irradiation (WBI) after conservative surgery for ductal carcinoma in situ (DCIS) reduces local recurrence. We investigated whether a tumour bed boost after WBI improved outcomes, and examined radiation dose fractionation sensitivity for non-low-risk DCIS.

methodsThe study was an international, randomised, unmasked, phase 3 trial involving 136 participating centres of six clinical trials organisations in 11 countries (Australia, New Zealand, Singapore, Canada, the Netherlands, Belgium, France, Switzerland, Italy, Ireland, and the UK). Eligible patients were women aged 18 years or older with unilateral, histologically proven, non-low-risk DCIS treated by breast-conserving surgery with at least 1 mm of clear radial resection margins. They were assigned to one of four groups (1:1:1:1) of no tumour bed boost versus boost after conventional versus hypofractionated WBI, or randomly assigned to one of two groups (1:1) of no boost versus boost after each centre prespecified conventional or hypofractionated WBI. The conventional WBI used was 50 Gy in 25 fractions, and hypofractionated WBI was 42·5 Gy in 16 fractions. A boost dose of 16 Gy in eight fractions, if allocated, was delivered after WBI. Patients and clinicians were not masked to treatment allocation. The primary endpoint was time to local recurrence. This trial is registered with ClinicalTrials.gov (NCT00470236).

findingsBetween June 25, 2007, and June 30, 2014, 1608 patients were randomly assigned to have no boost (805 patients) or boost (803 patients). Conventional WBI was given to 831 patients, and hypofractionated WBI was given to 777 patients. Median follow-up was 6·6 years. The 5-year free-from-local-recurrence rates were 92·7% (95% CI 90·6-94·4%) in the no-boost group and 97·1% (95·6-98·1%) in the boost group (hazard ratio 0·47; 0·31-0·72; p<0·001). The boost group had higher rates of grade 2 or higher breast pain (10% [8-12%] vs 14% [12-17%], p=0·003) and induration (6% [5-8%] vs 14% [11-16%], p<0·001).

interpretationIn patients with resected non-low-risk DCIS, a tumour bed boost after WBI reduced local recurrence with an increase in grade 2 or greater toxicity. The results provide the first randomised trial data to support the use of boost radiation after postoperative WBI in these patients to improve local control. The international scale of the study supports the generalisability of the results.

fundingNational Health and Medical Research Council of Australia, Susan G Komen for the Cure, Breast Cancer Now, OncoSuisse, Dutch Cancer Society, Canadian Cancer Trials Group.

Indexed as

Breast NeoplasmsCarcinoma, Intraductal, NoninfiltratingCanadaDose Fractionation, RadiationFemaleHumansMastectomy, SegmentalNeoplasm Recurrence, LocalNeoplasm StagingRadiation Dosage

Identifiers

PMID35934006
OpenAlexW4292954944

What OpenQuestion holds

Textmetadata
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.