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Brief Title: Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast
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
Study ID: NCT00470236
Brief 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. 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.
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. 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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, Antwerpen, , Belgium
Cliniques Univeritaires St Luc, Brussel, , Belgium
Universitair Zielenhusi, Brussel, , Belgium
Hopital De Jolimont, Haine St 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, Quebec, , 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, Munsterlingen, , Switzerland
Kantonsspital St. Gallen, St. 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, Middlesborough, , 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
Name: Boon Chua
Affiliation: Prince of Wales Hospital Randwick
Role: STUDY_CHAIR