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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00138814
Registration number
NCT00138814
Ethics application status
Date submitted
29/08/2005
Date registered
30/08/2005
Date last updated
15/12/2005
Titles & IDs
Public title
Boost Use in Breast Conservation Radiotherapy
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Scientific title
A Randomised Comparison of Breast Conservation With or Without Lumpectomy Radiotherapy Boost
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Secondary ID [1]
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96/84 Graham
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Local failure of breast cancer at 72 month median follow-up and 10 year median follow-up for final analysis
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Local control translating to survival over 10 year median follow-up
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Quality of life at yearly intervals with reference to baseline
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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Breast cosmesis - patient assessment and photos
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Assessment method [3]
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Timepoint [3]
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Eligibility
Key inclusion criteria
* Histologically proven carcinoma of the breast, T1-2 (0-5cm) N0-1, M0.
* Pure ductal carcinoma in situ accepted if completely excised.
* Any receptor status.
* Extensive intraductal cancer (EIC) accepted if completely excised.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Unable to consent
* Vascular/collagen disorder
* Prior malignancy except minor skin squamous cell or basal cell carcinoma or carcinoma in-situ of the cervix .
* Gross multifocal disease
* Involvement of margins.
* Bilateral breast cancer
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/1997
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Liverpool Hospital - Sydney
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Recruitment hospital [2]
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Cancer Care Centre, St George Hospital - Sydney
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Recruitment hospital [3]
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Wollongong Hospital - Wollongong
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Recruitment postcode(s) [1]
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2170 - Sydney
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Recruitment postcode(s) [2]
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2217 - Sydney
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Recruitment postcode(s) [3]
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2500 - Wollongong
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Funding & Sponsors
Primary sponsor type
Other
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Name
St George Hospital, Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a two arm randomized study for patients who are undergoing radiotherapy following breast conservation surgery for breast cancer. Local recurrence of breast cancer will be compared for patients receiving boost or no boost radiotherapy.
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Trial website
https://clinicaltrials.gov/study/NCT00138814
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Trial related presentations / publications
Browne LH, Graham PH. Good intentions and ICH-GCP: Trial conduct training needs to go beyond the ICH-GCP document and include the intention-to-treat principle. Clin Trials. 2014 Dec;11(6):629-34. doi: 10.1177/1740774514542620. Epub 2014 Jul 14. Hau E, Browne L, Capp A, Delaney GP, Fox C, Kearsley JH, Millar E, Nasser EH, Papadatos G, Graham PH. The impact of breast cosmetic and functional outcomes on quality of life: long-term results from the St. George and Wollongong randomized breast boost trial. Breast Cancer Res Treat. 2013 May;139(1):115-23. doi: 10.1007/s10549-013-2508-z. Epub 2013 Apr 12. Hau E, Browne LH, Khanna S, Cail S, Cert G, Chin Y, Clark C, Inder S, Szwajcer A, Graham PH. Radiotherapy breast boost with reduced whole-breast dose is associated with improved cosmesis: the results of a comprehensive assessment from the St. George and Wollongong randomized breast boost trial. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):682-9. doi: 10.1016/j.ijrobp.2010.11.025. Epub 2011 Jan 20. Millar EK, Graham PH, O'Toole SA, McNeil CM, Browne L, Morey AL, Eggleton S, Beretov J, Theocharous C, Capp A, Nasser E, Kearsley JH, Delaney G, Papadatos G, Fox C, Sutherland RL. Prediction of local recurrence, distant metastases, and death after breast-conserving therapy in early-stage invasive breast cancer using a five-biomarker panel. J Clin Oncol. 2009 Oct 1;27(28):4701-8. doi: 10.1200/JCO.2008.21.7075. Epub 2009 Aug 31.
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Public notes
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Contacts
Principal investigator
Name
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Associate Prof. Peter H Graham, MBBS FRANZCR
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Address
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Cancer Care Centre, St George Hospital, Sydney, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Associate Prof. Peter H Graham, MBBS FRANZCR
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Address
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Country
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Phone
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+61 29350 3912
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00138814
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