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Carcinoma, Ductal, BreastDCISNCT00470236

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

A study testing Standard WB fractionation, Shorter WB fractionation and Standard WB fractionation+Boost in people with Carcinoma, Ductal, Breast, run by Trans Tasman Radiation Oncology Group at 120 sites in 11 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Hypotheses: 1. The addition of tumour bed boost after BCS in women with non-low risk DCIS reduces the risk of local recurrence (invasive or intraductal recurrence in the ipsilateral breast). 2. The risk of local recurrence in the shorter fractionation arm is not worse than that for the standard fractionation arm. 3. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Carcinoma, Ductal, Breast
What is being tested?
Standard WB fractionation, Shorter WB fractionation and Standard WB fractionation+Boost
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,608 participants
Where
120 sitesin 11 countries
Study dates
Jun 2007to Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must fulfill all of the following criteria for admission to study:
  • Women ≥ 18 years.
  • Histologically proven DCIS of the breast without an invasive component.
  • Bilateral mammograms performed within 6 months prior to randomization.
  • Clinically node-negative.
  • Treated by breast conserving surgery (primary excision or re-excision) with complete microscopic excision and clear radial margins of ≥1 mm* (*Patients with superficial or deep resection margin of <1 mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia).
Show all 24Show fewer
  • Women who are at high risk of local recurrence due to:
  • Age < 50 years; OR
  • Age ≥ 50 years plus at least one of the following:
  • Symptomatic presentation
  • Palpable tumour
  • Multifocal disease
  • Microscopic tumour size ≥ 1.5 cm in maximum dimension
  • Intermediate or high nuclear grade
  • Central necrosis
  • Comedo histology
  • Radial* surgical resection margin < 10 mm. (*Patients with superficial or deep resection margin of < 10 mm are eligible if surgery has not removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia.)
  • Assessed by surgeon and radiation oncologist to be suitable for breast conserving therapy including whole breast RT.
  • Ability to tolerate protocol treatment.
  • Protocol RT should preferably commence within 8 weeks but must commence no later than 12 weeks from the last surgical procedure.
  • ECOG performance status 0, 1 or 2.
  • Patient's life expectancy > 5 years.
  • Availability for long-term follow-up.
  • Written informed consent.

Who cannot join

  • Patients who fulfill any of the following criteria are not eligible for admission to study:
  • Multicentric disease or extensive microcalcifications that could not be completely excised by breast conserving surgery with radial margins of ≥1 mm*.
  • Patients with superficial and/or deep margin of <1 mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia.
  • Presence of tumour cells in lymph nodes detected using H\&E or immunohistochemical examination (if lymph node biopsy or dissection has been performed).
  • Locally recurrent breast cancer.
  • Previous DCIS or invasive cancer of the contralateral breast.
Show all 15Show fewer
  • Bilateral DCIS of the breasts
  • Synchronous invasive carcinoma of the contralateral breast
  • Other concurrent or previous malignancies except:
  • Non-melanomatous skin cancer;
  • Carcinoma in situ of the cervix or endometrium; and
  • Invasive carcinoma of the cervix, endometrium, colon, thyroid and melanoma treated at least five years prior to study admission without disease recurrence.
  • Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g., scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).
  • ECOG performance status ≥ 3.
  • Women who are pregnant or lactating.

Trial locations and contacts

120 sites in 11 countries.

120 sites in 11 countries

United Kingdom39 sites

  • Aberdeen Royal Infirmary

    Aberdeen

  • Basildon University Hospital

    Basildon

  • Belfast City Hospital

    Belfast

  • Queen Elizabeth Hospital

    Birmingham

  • Sandwell and West Birmingham Hospitals NHS Trust

    Birmingham

  • Pilgram Hospital

    Boston, Lincolnshire

  • Bristol Haematology & Oncology

    Bristol

  • Queens Hospital Burton

    Burton-on-Trent, Staffordshire

  • Gloucestershire Royal & Cheltenham General Hospitals

    Cheltenham, Gloucestershire

  • Colchester Hospital

    Colchester

  • Coventry Arden Cancer Centre

    Coventry

  • Royal Derby Hospital

    Derby

  • Dumfries & Galloway Royal Infirmary

    Dumfries

  • Queen Margaret Hospital

    Dunfermline

  • Edinburgh Western General Hospital

    Edinburgh

  • The Beatson West of Scotland Cancer Centre

    Glasgow

  • Royal Surrey County Hospital

    Guildford

  • Ipswich Hospital

    Ipswich

  • Kidderminster Hospital

    Kidderminster

  • Leicester Royal Infirmary

    Leicester

  • Lincoln County Hospital

    Lincoln

  • Imperial College Healthcare Charing Cross

    London

  • James Cook University Hospital

    Middlesbrough

  • Mount Vernon Cancer Centre

    Northwood, Middlesex

  • Nottingham University Hospitals

    Nottingham

  • Churchill Hospital

    Oxford, Headington

  • Royal Alexandra Hospital

    Paisley

  • Alexandra Hospital

    Redditch

  • Weston Park Hospital

    Sheffield

  • The Shrewsbury and Telford Hospital NHS Trust

    Shrewsbury

  • Ealing Hospital

    Southall, Middlesex

  • Southend University Hopstial

    Southend

  • Stafford Hospital

    Stafford

  • University of North Staffordshire

    Stoke-on-Trent, Staffordshire

  • Royal Marsden

    Sutton

  • Kings Mill Hospital Nottingham

    Sutton in Ashfield, Nottinghamshire

  • Musgrove Park Hospital

    Taunton, Somerset

  • Warwick Hospital

    Warwick

  • New Cross Hospital

    Wolverhampton

Other trials in United Kingdom

Australia26 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Premion - Wesley

    Auchenflower, Queensland, 4006

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4006

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560

  • Barwon Health - Andrew Love Cancer Care Centre, Geelong Hospital

    Geelong, Victoria, 3220

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Nepean Cancer Care Centre

    Kingswood, New South Wales

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Launceston General Hospital

    Launceston, Tasmania, 7250

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3002

  • Austin Hospital

    Melbourne, Victoria, 3084

  • William Buckland Radiotherapy Centre, Alfred Hospital

    Melbourne, Victoria, 3181

  • Genesis Cancer Care (previously Premion) - Nambour

    Nambour, Queensland

  • Sir Charles Gardiner Hospital

    Nedlands, Western Australia, 6009

  • Royal Perth Hospital

    Perth, Western Australia, 6001

  • Perth Radiation Oncology

    Perth, Western Australia

  • Radiation Oncology - Mater Centre

    South Brisbane, Queensland, 4101

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Toowoomba Cancer Research Centre

    Toowoomba, Queensland

  • North Queensland Oncology Service

    Townsville, Queensland, 4810

  • Genesis Cancer Care (previously Premion) - Tugun

    Tugun, Queensland, 4224

  • Riverina Cancer Care Centre

    Wagga Wagga, New South Wales, 2650

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Westmead Hospital

    Wentworthville, New South Wales, 2145

Other trials in Australia

Canada20 sites

  • Nova Scotia Cancer Centre

    Halifax

  • Jurvanski Cancer Centre

    Hamilton

  • Notre Dame Hospital

    Hearst

  • BCCA Southern Interior - CAVK

    Kelowna

  • London Regional Cancer Program

    London

  • Saint John Regional Hospital

    Miramichi

  • Leon Richard Oncology Centre

    Moncton

  • Hospital Maisonneuve-Rosemont

    Montreal

  • Lakeridge Health

    Oshawa

  • CHUQ L'Hotel-Dieu de Quebec

    Québec

  • McGill University Department of Oncology

    Sainte-Anne-de-Bellevue

  • Allan Blair Cancer Centre

    Saskatoon

  • Saskatoon Cancer Centre

    Saskatoon

  • Universite de Sherbrooke - CUGH

    Sherbrooke

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay

  • Odette Cancer Centre

    Toronto

  • Princess Margaret Hospital

    Toronto

  • BCCA Vancouver Centre

    Victoria

  • Vancouver Island Cancer Centre

    Victoria

  • Cancer Care Manitoba

    Winnipeg

Other trials in Canada

Netherlands9 sites

  • Academisch Medisch Centrum

    Amsterdam

  • Cancer Institute Antoni Van Leeuwenhoekziekenhuis

    Amsterdam

  • Arnhem 'S Radiotherapeutisch Instituut

    Arnhem

  • Reinier de Graaf Groep

    Delft

  • University Medical Centre Groningen

    Groningen

  • Leiden University Medical Centre

    Leiden

  • Maastricht Radiation Oncology Maastro Clinic

    Maastricht

  • Medisch Centrum Haaglanden

    Westeinde

  • ISALA Klinieken

    Zwolle

Other trials in Netherlands

Switzerland8 sites

  • University Hospital Basel

    Basel

  • IOSI

    Bellinzona

  • Inselspital Bern

    Bern

  • Kantonsspital Graubunden

    Chur

  • Kantonsspital Munsterlingen

    Münsterlingen

  • Kantonsspital St. Gallen

    Sankt Gallen

  • Brust-Zentrum Zurich-Seefeld

    Zurich

  • Klinik Hirslanden

    Zurich

Other trials in Switzerland

Belgium7 sites

  • Onze Lieve Vrouw Ziekenhuis

    Aalst

  • ZNA Middelheim

    Antwerp

  • Cliniques Univeritaires St Luc

    Brussels

  • Universitair Zielenhusi

    Brussels

  • Hopital De Jolimont

    Haine-Saint-Paul

  • AZ Groeninghe - Campus Maria's Voorzienigheid

    Kortrijk

  • Algemeen Ziekenhis Sint-Augustinus

    Wilrijk

Other trials in Belgium

Ireland3 sites

  • Cork University Hospital

    Cork

  • University Hospital Galway

    Galway

  • SLRON (St Luke's Rad Onc Network)

    Rathgar

Other trials in Ireland

New Zealand3 sites

  • Auckland Hospital

    Auckland, 1001

  • Christchurch Hospital

    Christchurch, 8011

  • Waikato Hospital

    Hamilton, 3204

Other trials in New Zealand

France2 sites

  • Chr De Grenoble - La Tronche

    Grenoble

  • Centre Antine Lacassagne

    Nice

Other trials in France

Italy2 sites

  • Centro Di Riferimento Oncologico - Aviano

    Aviano

  • Fondazione Salvatore Maugeri

    Pavia

Other trials in Italy

Singapore1 site

  • National University Hospital

    Singapore, 119074

Other trials in Singapore

About this study

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

Hypotheses:

  1. The addition of tumour bed boost after BCS in women with non-low risk DCIS reduces the risk of local recurrence (invasive or intraductal recurrence in the ipsilateral breast).
  2. The risk of local recurrence in the shorter fractionation arm is not worse than that for the standard fractionation arm.
  3. A molecular signature predictive of invasive recurrence of DCIS will be detectable and the molecular signature may eventually have clinical utility for therapy individualization.
Read more

Overall Objectives:

  1. To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy.
  2. To individualize treatment selection for women with DCIS to achieve long term disease control with minimal toxicity.
Read the detailed description

Specific objectives:

  1. To evaluate time to local recurrence in women with DCIS treated with breast conserving surgery followed by:
  • whole breast RT alone versus whole breast RT plus tumour bed boost;
  • RT using the standard fractionation schedule versus the shorter schedule.
  1. To evaluate time to disease recurrence and overall survival in women with DCIS treated with breast conserving surgery followed by:
  • whole breast RT alone versus whole breast RT plus tumour bed boost;
  • RT using the standard fractionation schedule versus the shorter schedule.
  1. To compare the toxicity of:
  • whole breast RT alone versus whole breast RT plus tumour bed boost;
  • RT using the standard fractionation schedule versus the shorter schedule.
  1. To compare the cosmetic outcome of:
  • whole breast RT alone versus whole breast RT plus tumour bed boost;
  • RT using the standard fractionation schedule versus the shorter schedule.
  1. To identify a molecular signature predictive of invasive recurrence of DCIS to facilitate therapy individualization.
  2. To assess inter-relationship of biomarkers and relationship between biomarker expression and specific histopathologic features of DCIS.
  3. To evaluate the quality of life of women treated with:
  • whole breast RT alone versus whole breast RT plus tumour bed boost;
  • RT using the standard fractionation schedule versus the shorter schedule.
Being tested
Standard WB fractionation, Shorter WB fractionation, Standard WB fractionation+Boost, Shorter WB fractionation + Boost
Keywords
Ductal carcinoma in-situ, Breast conserving therapy, Whole breast radiation therapy, Tumour bed boost, Fractionation schedules, Completely excised non-low risk DCIS
Medical subject headings
Carcinoma, Ductal, Breast, Carcinoma, Intraductal, Noninfiltrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard WB fractionationRadiation

    Also called Radiation

    A total dose of 50 Gy in 25 fractions in 2-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).

  • Shorter WB fractionationRadiation

    Also called Radiation

    A total dose of 42.5 Gy in 16 fractions in 2.656-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).

  • Standard WB fractionation+BoostRadiation

    Also called Radiation

    Whole Breast: A total dose of 50 Gy in 25 fractions in 2-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).

    Tumour bed: A total dose of 10 Gy in 5 fractions in 2-Gy daily fractions, 5 fractions per week.

  • Shorter WB fractionation + BoostRadiation

    Also called Radiation

    Whole breast: A total dose of 42.5 Gy in 16 fractions in 2.656-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).

    Tumour bed: A total dose of 10 Gy in 4 fractions in 2.5-Gy daily fractions, 4 fractions per week.

Study groups in NCT00470236
Study groupRoleWhat they receive
Arm 1 (Standard WB Fractionation)Active comparatorWhole Breast RT alone - Standard fractionation schedule (50GY/25 Fractions/35days)
Receives: Radiation: Standard WB fractionation
Arm 2 (Shorter WB Fractionation)ExperimentalWhole Breast RT alone - Shorter fractionation schedule (42.5 Gy/16 fractions/22 days)
Receives: Radiation: Shorter WB fractionation
Arm 3 (Standard WB fractionation+Boost)Active comparatorWhole Breast RT + tumor bed boost - Standard fractionation schedule (50 Gy/25 fractions/35 days; Boost 16 Gy/8 fractions/10 days)
Receives: Radiation: Standard WB fractionation+Boost
Arm 4 (Shorter WB fractionation + Boost)ExperimentalWhole breast RT + tumour bed boost - Shorter fractionation schedule (42.5 Gy/16 fractions/22 days; Boost 16 Gy/8 fractions/10 days)
Receives: Radiation: Shorter WB fractionation + Boost

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to local recurrence, measured from the date of randomization to the date of first evidence of local recurrence.

    Measured: Main analysis after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up.

Secondary outcomes (5)

  1. Overall survival

    Measured: Measured from the date of randomization to the date of death from any cause. Main analysis of secondary outcomes after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up.

  2. Time to disease recurrence

    Measured: Measured from the date of randomization to the date of first evidence of recurrent disease. Main analysis of secondary outcomes after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up.

  3. Cosmetic Outcome

    Measured: Cosmetic assessment will take place at baseline, 12, 36 and 60 months post RT.

  4. Radiation toxicity

    Measured: Assessed at baseline, last week of RT, 3, 6, and 12 months post RT and then yearly until year 10.

  5. Quality of Life change

    Measured: Assessed at baseline, last week of RT, 6, 12, 24, 60 & 120 months post RT.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionJun 2024 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,608 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00470236
Sponsor's protocol ID
TROG 07.01
Other IDs
NHMRC 454390, BIG 3-07, NCIC CTG MA.33, BOOG 2009-03, ICORG 10-06, EORTC 22085-10083, IBCSG 38-10, SCTBG 2009MayPR55
Acronym
DCIS
Status last verified
Mar 2023
First submitted
3 May 2007
Last updated
22 Mar 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Chua BH, Link EK, Kunkler IH, Whelan TJ, Westenberg AH, Gruber G, Bryant G, Ahern V, Purohit K, Graham PH, Akra M, McArdle O, O'Brien P, Harvey JA, Kirkove C, Maduro JH, Campbell ID, Delaney GP, Martin JD, Vu TTT, Muanza TM, Neal A, Olivotto IA; BIG 3-07/TROG 07.01 trial investigators. 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. Lancet. 2022 Aug 6;400(10350):431-440. doi: 10.1016/S0140-6736(22)01246-6.

    PubMed 35934006

  • King MT, Link EK, Whelan TJ, Olivotto IA, Kunkler I, Westenberg AH, Gruber G, Schofield P, Chua BH; BIG 3-07/TROG 07.01 trial investigators. Quality of life after breast-conserving therapy and adjuvant radiotherapy for non-low-risk ductal carcinoma in situ (BIG 3-07/TROG 07.01): 2-year results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2020 May;21(5):685-698. doi: 10.1016/S1470-2045(20)30085-1. Epub 2020 Mar 20.

    PubMed 32203696

Questions about this trial

What is this clinical trial studying?

A study testing Standard WB fractionation, Shorter WB fractionation and Standard WB fractionation+Boost in people with Carcinoma, Ductal, Breast, run by Trans Tasman Radiation Oncology Group at 120 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United Kingdom, Australia, Canada, Netherlands, Switzerland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to local recurrence, measured from the date of randomization to the date of first evidence of local recurrence. (time frame: Main analysis after all patients have completed 5 years of follow-up. Updated analysis after 10 years of follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00470236, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.

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