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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
Trial website
Trial related presentations / publications
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
GrahamP@sesahs.nsw.gov.au
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