Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast
This trial is active, not recruiting.
|Condition||carcinoma, ductal, breast|
|Treatments||standard wb fractionation, shorter wb fractionation, standard wb fractionation+boost, shorter wb fractionation + boost|
|Sponsor||Trans-Tasman Radiation Oncology Group (TROG)|
|Collaborator||Breast International Group|
|Start date||June 2007|
|End date||June 2024|
|Trial size||1608 participants|
|Trial identifier||NCT00470236, BIG 3-07, BOOG 2009-03, EORTC 22085-10083, IBCSG 38-10, ICORG 10-06, NCIC CTG MA.33, NHMRC 454390, SCTBG 2009MayPR55, TROG 07.01|
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.
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Campbelltown, Australia||Campbelltown Hospital||no longer recruiting|
|Kingswood, Australia||Nepean Cancer Care Centre||no longer recruiting|
|Kogarah, Australia||St George Hospital||no longer recruiting|
|Liverpool, Australia||Liverpool Hospital||no longer recruiting|
|St Leonards, Australia||Royal North Shore Hospital||no longer recruiting|
|Wagga Wagga, Australia||Riverina Cancer Care Centre||no longer recruiting|
|Waratah, Australia||Calvary Mater Newcastle||no longer recruiting|
|Wentworthville, Australia||Westmead Hospital||no longer recruiting|
|Auchenflower, Australia||Premion - Wesley||no longer recruiting|
|Brisbane, Australia||Royal Brisbane and Women's Hospital||no longer recruiting|
|Nambour, Australia||Genesis Cancer Care (previously Premion) - Nambour||no longer recruiting|
|South Brisbane, Australia||Radiation Oncology - Mater Centre||no longer recruiting|
|Toowoomba, Australia||Toowoomba Cancer Research Centre||no longer recruiting|
|Townsville, Australia||North Queensland Oncology Service||no longer recruiting|
|Tugun, Australia||Genesis Cancer Care (previously Premion) - Tugun||no longer recruiting|
|Wooloongabba, Australia||Princess Alexandra Hospital||no longer recruiting|
|Adelaide, Australia||Royal Adelaide Hospital||no longer recruiting|
|Hobart, Australia||Royal Hobart Hospital||no longer recruiting|
|Launceston, Australia||Launceston General Hospital||no longer recruiting|
|Geelong, Australia||Barwon Health - Andrew Love Cancer Care Centre, Geelong Hospital||no longer recruiting|
|Heidelburg, Australia||Austin Hospital||no longer recruiting|
|Melbourne, Australia||Peter MacCallum Cancer Centre||no longer recruiting|
|Prahan, Australia||William Buckland Radiotherapy Centre, Alfred Hospital||no longer recruiting|
|Nedlands, Australia||Sir Charles Gardiner Hospital||no longer recruiting|
|Perth, Australia||Royal Perth Hospital||no longer recruiting|
|Perth, Australia||Perth Radiation Oncology||no longer recruiting|
|Aalst, Belgium||Onze Lieve Vrouw Ziekenhuis||no longer recruiting|
|Antwerpen, Belgium||ZNA Middelheim||no longer recruiting|
|Brussel, Belgium||Cliniques Univeritaires St Luc||no longer recruiting|
|Brussel, Belgium||Universitair Zielenhusi||no longer recruiting|
|Haine St Paul, Belgium||Hopital De Jolimont||no longer recruiting|
|Kortrijk, Belgium||AZ Groeninghe - Campus Maria's Voorzienigheid||no longer recruiting|
|Wilrijk, Belgium||Algemeen Ziekenhis Sint-Augustinus||no longer recruiting|
|Hamilton, Canada||Jurvanski Cancer Centre||no longer recruiting|
|Hearst, Canada||Notre Dame Hospital||no longer recruiting|
|Kelowna, Canada||BCCA Southern Interior - CAVK||no longer recruiting|
|London, Canada||London Regional Cancer Program||no longer recruiting|
|Manitoba, Canada||Cancer Care||no longer recruiting|
|Miramichi, Canada||Saint John Regional Hospital||no longer recruiting|
|Moncton, Canada||Leon Richard Oncology Centre||no longer recruiting|
|Montreal, Canada||Hospital Maisonneuve-Rosemont||no longer recruiting|
|Oshawa, Canada||Lakeridge Health||no longer recruiting|
|Province of Nova Scotia, Canada||Nova Scotia Cancer Centre||no longer recruiting|
|Quebec, Canada||CHUQ L'Hotel-Dieu de Quebec||no longer recruiting|
|Sainte-Anne-de-Bellevue, Canada||McGill University Department of Oncology||no longer recruiting|
|Saskatoon, Canada||Allan Blair Cancer Centre||no longer recruiting|
|Saskatoon, Canada||Saskatoon Cancer Centre||no longer recruiting|
|Sherbrooke, Canada||Universite de Sherbrooke - CUGH||no longer recruiting|
|Thunder Bay, Canada||Thunder Bay Regional Health Sciences Centre||no longer recruiting|
|Toronto, Canada||Odette Cancer Centre||no longer recruiting|
|Toronto, Canada||Princess Margaret Hospital||no longer recruiting|
|Victoria, Canada||BCCA Vancouver Centre||no longer recruiting|
|Victoria, Canada||Vancouver Island Cancer Centre||no longer recruiting|
|Grenoble, France||Chr De Grenoble - La Tronche||no longer recruiting|
|Nice, France||Centre Antine Lacassagne||no longer recruiting|
|Cork, Ireland||Cork University Hospital||no longer recruiting|
|Galway, Ireland||University Hospital Galway||no longer recruiting|
|Rathgar, Ireland||SLRON (St Luke's Rad Onc Network)||no longer recruiting|
|Aviano, Italy||Centro Di Riferimento Oncologico - Aviano||no longer recruiting|
|Pavia, Italy||Fondazione Salvatore Maugeri||no longer recruiting|
|Amsterdam,, Netherlands||Academisch Medisch Centrum||no longer recruiting|
|Amsterdam, Netherlands||Cancer Institute Antoni Van Leeuwenhoekziekenhuis||no longer recruiting|
|Arnhem, Netherlands||Arnhem 'S Radiotherapeutisch Instituut||no longer recruiting|
|Delft, Netherlands||Reinier de Graaf Groep||no longer recruiting|
|Groningen, Netherlands||University Medical Centre Groningen||no longer recruiting|
|Leiden, Netherlands||Leiden University Medical Centre||no longer recruiting|
|Maastricht, Netherlands||Maastricht Radiation Oncology Maastro Clinic||no longer recruiting|
|Westeinde, Netherlands||Medisch Centrum Haaglanden||no longer recruiting|
|Zwolle, Netherlands||ISALA Klinieken||no longer recruiting|
|Auckland, New Zealand||Auckland Hospital||no longer recruiting|
|Christchurch, New Zealand||Christchurch Hospital||no longer recruiting|
|Waikato, New Zealand||Waikato Hospital||no longer recruiting|
|Singapore, Singapore||National University Hospital||no longer recruiting|
|Basel, Switzerland||University Hospital Basel||no longer recruiting|
|Bellinzona, Switzerland||IOSI||no longer recruiting|
|Bern, Switzerland||Inselspital Bern||no longer recruiting|
|Chur, Switzerland||Kantonsspital Graubunden||no longer recruiting|
|Munsterlingen, Switzerland||Kantonsspital Munsterlingen||no longer recruiting|
|St. Gallen, Switzerland||Kantonsspital St. Gallen||no longer recruiting|
|Zurich, Switzerland||Brust-Zentrum Zurich-Seefeld||no longer recruiting|
|Zurich, Switzerland||Klinik Hirslanden||no longer recruiting|
|Cheltenham, United Kingdom||Gloucestershire Royal & Cheltenham General Hospitals||no longer recruiting|
|Oxford, United Kingdom||Churchill Hospital||no longer recruiting|
|Boston, United Kingdom||Pilgram Hospital||no longer recruiting|
|Northwood, United Kingdom||Mount Vernon Cancer Centre||no longer recruiting|
|Southall, United Kingdom||Ealing Hospital||no longer recruiting|
|Sutton-In-Ashfield, United Kingdom||Kings Mill Hospital Nottingham||no longer recruiting|
|Taunton, United Kingdom||Musgrove Park Hospital||no longer recruiting|
|Burton-On-Trent, United Kingdom||Queens Hospital Burton||no longer recruiting|
|Stoke-On-Trent, United Kingdom||University of North Staffordshire||no longer recruiting|
|Aberdeen, United Kingdom||Aberdeen Royal Infirmary||no longer recruiting|
|Basildon, United Kingdom||Basildon University Hospital||no longer recruiting|
|Belfast, United Kingdom||Belfast City Hospital||no longer recruiting|
|Birmingham, United Kingdom||Queen Elizabeth Hospital||no longer recruiting|
|Birmingham, United Kingdom||Sandwell and West Birmingham Hospitals NHS Trust||no longer recruiting|
|Bristol, United Kingdom||Bristol Haematology & Oncology||no longer recruiting|
|Colchester, United Kingdom||Colchester Hospital||no longer recruiting|
|Coventry, United Kingdom||Coventry Arden Cancer Centre||no longer recruiting|
|Derby, United Kingdom||Royal Derby Hospital||no longer recruiting|
|Dumfries, United Kingdom||Dumfries & Galloway Royal Infirmary||no longer recruiting|
|Dunfermline, United Kingdom||Queen Margaret Hospital||no longer recruiting|
|Edinburgh, United Kingdom||Edinburgh Western General Hospital||no longer recruiting|
|Glascow, United Kingdom||The Beatson West of Scotland Cancer Centre||no longer recruiting|
|Ipswich, United Kingdom||Ipswich Hospital||no longer recruiting|
|Kidderminster, United Kingdom||Kidderminster Hospital||no longer recruiting|
|Leicester, United Kingdom||Leicester Royal Infirmary||no longer recruiting|
|Lincoln, United Kingdom||Lincoln County Hospital||no longer recruiting|
|London, United Kingdom||Imperial College Healthcare Charing Cross||no longer recruiting|
|Middlesborough, United Kingdom||James Cook University Hospital||no longer recruiting|
|Nottingham, United Kingdom||Nottingham University Hospitals||no longer recruiting|
|Paisley, United Kingdom||Royal Alexandra Hospital||no longer recruiting|
|Redditch, United Kingdom||Alexandra Hospital||no longer recruiting|
|Sheffield, United Kingdom||Weston Park Hospital||no longer recruiting|
|Shrewsbury, United Kingdom||The Shrewsbury and Telford Hospital NHS Trust||no longer recruiting|
|Southend, United Kingdom||Southend University Hopstial||no longer recruiting|
|Stafford, United Kingdom||Stafford Hospital||no longer recruiting|
|Surrey, United Kingdom||Royal Surrey County Hospital||no longer recruiting|
|Sutton, United Kingdom||Royal Marsden||no longer recruiting|
|Warwick, United Kingdom||Warwick Hospital||no longer recruiting|
|Wolverhampton, United Kingdom||New Cross Hospital||no longer recruiting|
|Intervention model||parallel assignment|
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.
time frame: 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.
Time to disease recurrence
time frame: 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.
time frame: Cosmetic assessment will take place at baseline, 12, 36 and 60 months post RT.
time frame: Assessed at baseline, last week of RT, 3, 6, and 12 months post RT and then yearly until year 10.
Quality of Life
time frame: Assessed at baseline, last week of RT, 6, 12, 24, 60 & 120 months post RT.
Female participants at least 18 years old.
- 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.
- 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.
|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|
|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.|
Call for more information