Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast
NCT ID: NCT00470236
Last Updated: 2023-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1608 participants
INTERVENTIONAL
2007-06-30
2024-06-30
Brief Summary
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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.
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.
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Detailed Description
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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.
2. 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.
3. 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.
4. 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.
5. To identify a molecular signature predictive of invasive recurrence of DCIS to facilitate therapy individualization.
6. To assess inter-relationship of biomarkers and relationship between biomarker expression and specific histopathologic features of DCIS.
7. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 (Standard WB Fractionation)
Whole Breast RT alone - Standard fractionation schedule (50GY/25 Fractions/35days)
Standard WB fractionation
A total dose of 50 Gy in 25 fractions in 2-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).
Arm 2 (Shorter WB Fractionation)
Whole Breast RT alone - Shorter fractionation schedule (42.5 Gy/16 fractions/22 days)
Shorter WB fractionation
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).
Arm 3 (Standard WB fractionation+Boost)
Whole Breast RT + tumor bed boost - Standard fractionation schedule (50 Gy/25 fractions/35 days; Boost 16 Gy/8 fractions/10 days)
Standard WB fractionation+Boost
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.
Arm 4 (Shorter WB fractionation + Boost)
Whole breast RT + tumour bed boost - Shorter fractionation schedule (42.5 Gy/16 fractions/22 days; Boost 16 Gy/8 fractions/10 days)
Shorter WB fractionation + Boost
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.
Interventions
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Standard WB fractionation
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 fractionation
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+Boost
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 + Boost
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
FEMALE
No
Sponsors
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Breast International Group
OTHER
NCIC Clinical Trials Group
NETWORK
Cancer Trials Ireland
NETWORK
Borstkanker Onderzoek Groep
NETWORK
ETOP IBCSG Partners Foundation
NETWORK
Scottish Cancer Trials Breast Group
UNKNOWN
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Trans Tasman Radiation Oncology Group
OTHER
Responsible Party
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Principal Investigators
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Boon Chua
Role: STUDY_CHAIR
Prince of Wales Hospital Randwick
Locations
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Campbelltown Hospital
Campbelltown, New South Wales, Australia
Nepean Cancer Care Centre
Kingswood, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Westmead Hospital
Wentworthville, New South Wales, Australia
Premion - Wesley
Auchenflower, Queensland, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Genesis Cancer Care (previously Premion) - Nambour
Nambour, Queensland, Australia
Radiation Oncology - Mater Centre
South Brisbane, Queensland, Australia
Toowoomba Cancer Research Centre
Toowoomba, Queensland, Australia
North Queensland Oncology Service
Townsville, Queensland, Australia
Genesis Cancer Care (previously Premion) - Tugun
Tugun, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Launceston General Hospital
Launceston, Tasmania, Australia
Barwon Health - Andrew Love Cancer Care Centre, Geelong Hospital
Geelong, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Austin Hospital
Melbourne, Victoria, Australia
William Buckland Radiotherapy Centre, Alfred Hospital
Melbourne, Victoria, Australia
Sir Charles Gardiner Hospital
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Perth Radiation Oncology
Perth, Western Australia, Australia
Onze Lieve Vrouw Ziekenhuis
Aalst, , Belgium
ZNA Middelheim
Antwerp, , Belgium
Cliniques Univeritaires St Luc
Brussels, , Belgium
Universitair Zielenhusi
Brussels, , Belgium
Hopital De Jolimont
Haine-Saint-Paul, , Belgium
AZ Groeninghe - Campus Maria's Voorzienigheid
Kortrijk, , Belgium
Algemeen Ziekenhis Sint-Augustinus
Wilrijk, , Belgium
Nova Scotia Cancer Centre
Halifax, , Canada
Jurvanski Cancer Centre
Hamilton, , Canada
Notre Dame Hospital
Hearst, , Canada
BCCA Southern Interior - CAVK
Kelowna, , Canada
London Regional Cancer Program
London, , Canada
Saint John Regional Hospital
Miramichi, , Canada
Leon Richard Oncology Centre
Moncton, , Canada
Hospital Maisonneuve-Rosemont
Montreal, , Canada
Lakeridge Health
Oshawa, , Canada
CHUQ L'Hotel-Dieu de Quebec
Québec, , Canada
McGill University Department of Oncology
Sainte-Anne-de-Bellevue, , Canada
Allan Blair Cancer Centre
Saskatoon, , Canada
Saskatoon Cancer Centre
Saskatoon, , Canada
Universite de Sherbrooke - CUGH
Sherbrooke, , Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, , Canada
Odette Cancer Centre
Toronto, , Canada
Princess Margaret Hospital
Toronto, , Canada
BCCA Vancouver Centre
Victoria, , Canada
Vancouver Island Cancer Centre
Victoria, , Canada
Cancer Care Manitoba
Winnipeg, , Canada
Chr De Grenoble - La Tronche
Grenoble, , France
Centre Antine Lacassagne
Nice, , France
Cork University Hospital
Cork, , Ireland
University Hospital Galway
Galway, , Ireland
SLRON (St Luke's Rad Onc Network)
Rathgar, , Ireland
Centro Di Riferimento Oncologico - Aviano
Aviano, , Italy
Fondazione Salvatore Maugeri
Pavia, , Italy
Academisch Medisch Centrum
Amsterdam, , Netherlands
Cancer Institute Antoni Van Leeuwenhoekziekenhuis
Amsterdam, , Netherlands
Arnhem 'S Radiotherapeutisch Instituut
Arnhem, , Netherlands
Reinier de Graaf Groep
Delft, , Netherlands
University Medical Centre Groningen
Groningen, , Netherlands
Leiden University Medical Centre
Leiden, , Netherlands
Maastricht Radiation Oncology Maastro Clinic
Maastricht, , Netherlands
Medisch Centrum Haaglanden
Westeinde, , Netherlands
ISALA Klinieken
Zwolle, , Netherlands
Auckland Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
National University Hospital
Singapore, , Singapore
University Hospital Basel
Basel, , Switzerland
IOSI
Bellinzona, , Switzerland
Inselspital Bern
Bern, , Switzerland
Kantonsspital Graubunden
Chur, , Switzerland
Kantonsspital Munsterlingen
Münsterlingen, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Brust-Zentrum Zurich-Seefeld
Zurich, , Switzerland
Klinik Hirslanden
Zurich, , Switzerland
Gloucestershire Royal & Cheltenham General Hospitals
Cheltenham, Gloucestershire, United Kingdom
Churchill Hospital
Oxford, Headington, United Kingdom
Pilgram Hospital
Boston, Lincolnshire, United Kingdom
Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom
Ealing Hospital
Southall, Middlesex, United Kingdom
Kings Mill Hospital Nottingham
Sutton in Ashfield, Nottinghamshire, United Kingdom
Musgrove Park Hospital
Taunton, Somerset, United Kingdom
Queens Hospital Burton
Burton-on-Trent, Staffordshire, United Kingdom
University of North Staffordshire
Stoke-on-Trent, Staffordshire, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Basildon University Hospital
Basildon, , United Kingdom
Belfast City Hospital
Belfast, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Sandwell and West Birmingham Hospitals NHS Trust
Birmingham, , United Kingdom
Bristol Haematology & Oncology
Bristol, , United Kingdom
Colchester Hospital
Colchester, , United Kingdom
Coventry Arden Cancer Centre
Coventry, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Dumfries & Galloway Royal Infirmary
Dumfries, , United Kingdom
Queen Margaret Hospital
Dunfermline, , United Kingdom
Edinburgh Western General Hospital
Edinburgh, , United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Royal Surrey County Hospital
Guildford, , United Kingdom
Ipswich Hospital
Ipswich, , United Kingdom
Kidderminster Hospital
Kidderminster, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Lincoln County Hospital
Lincoln, , United Kingdom
Imperial College Healthcare Charing Cross
London, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Nottingham University Hospitals
Nottingham, , United Kingdom
Royal Alexandra Hospital
Paisley, , United Kingdom
Alexandra Hospital
Redditch, , United Kingdom
Weston Park Hospital
Sheffield, , United Kingdom
The Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, , United Kingdom
Southend University Hopstial
Southend, , United Kingdom
Stafford Hospital
Stafford, , United Kingdom
Royal Marsden
Sutton, , United Kingdom
Warwick Hospital
Warwick, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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References
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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.
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.
Related Links
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Click here for more information about this study on the TROG official website
Other Identifiers
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NHMRC 454390
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
BIG 3-07
Identifier Type: OTHER
Identifier Source: secondary_id
NCIC CTG MA.33
Identifier Type: OTHER
Identifier Source: secondary_id
BOOG 2009-03
Identifier Type: OTHER
Identifier Source: secondary_id
ICORG 10-06
Identifier Type: OTHER
Identifier Source: secondary_id
EORTC 22085-10083
Identifier Type: OTHER
Identifier Source: secondary_id
IBCSG 38-10
Identifier Type: OTHER
Identifier Source: secondary_id
SCTBG 2009MayPR55
Identifier Type: OTHER
Identifier Source: secondary_id
TROG 07.01
Identifier Type: -
Identifier Source: org_study_id
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