Trial Review

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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
Scientific title
A Randomised Comparison of Breast Conservation With or Without Lumpectomy Radiotherapy Boost
Secondary ID [1] 0 0
96/84 Graham
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Local failure of breast cancer at 72 month median follow-up and 10 year median follow-up for final analysis
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Local control translating to survival over 10 year median follow-up
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Quality of life at yearly intervals with reference to baseline
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Breast cosmesis - patient assessment and photos
Timepoint [3] 0 0

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/1997
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [2] 0 0
Cancer Care Centre, St George Hospital - Sydney
Recruitment hospital [3] 0 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
2170 - Sydney
Recruitment postcode(s) [2] 0 0
2217 - Sydney
Recruitment postcode(s) [3] 0 0
2500 - Wollongong

Funding & Sponsors
Primary sponsor type
Other
Name
St George Hospital, Australia
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00138814
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.
Public notes

Contacts
Principal investigator
Name 0 0
Associate Prof. Peter H Graham, MBBS FRANZCR
Address 0 0
Cancer Care Centre, St George Hospital, Sydney, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Associate Prof. Peter H Graham, MBBS FRANZCR
Address 0 0
Country 0 0
Phone 0 0
+61 29350 3912
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00138814