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Boost Use in Breast Conservation Radiotherapy

Primary Purpose

Breast Neoplasms

Status
Unknown status
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Radiotherapy (boost versus no boost)
Sponsored by
St George Hospital, Australia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Neoplasm recurrence, local, Radiotherapy dosage, Cosmesis, Mastectomy, segmental

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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. 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

Sites / Locations

  • Liverpool HospitalRecruiting
  • Cancer Care Centre, St George HospitalRecruiting
  • Wollongong HospitalRecruiting

Outcomes

Primary Outcome Measures

Local failure of breast cancer at 72 month median follow-up and 10 year median follow-up for final analysis

Secondary Outcome Measures

Local control translating to survival over 10 year median follow-up
Quality of life at yearly intervals with reference to baseline
Breast cosmesis - patient assessment and photos

Full Information

First Posted
August 29, 2005
Last Updated
December 14, 2005
Sponsor
St George Hospital, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT00138814
Brief Title
Boost Use in Breast Conservation Radiotherapy
Official Title
A Randomised Comparison of Breast Conservation With or Without Lumpectomy Radiotherapy Boost
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2015 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
St George Hospital, Australia

4. Oversight

5. Study Description

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.
Detailed Description
A boost dose of radiation is commonly but not universally employed in breast conservation techniques. The potential disadvantages when a boost is employed include: Increased complexity of treatment Increased duration of treatment Increased travel, social/employment dislocation Increased complications Worse cosmesis and/or increased breast discomfort Increased difficulty in detecting recurrence. Prolongation of gap or increased delay for chemotherapy if indicated The potential advantages of a boost are the following: Reduced local failure rates Reduced local failure translating to improved survival Maximising cosmesis by reducing dose to larger breast volume None of the potential advantages have been clearly demonstrated in a controlled fashion although there are sound theoretical reasons that a boost will improve local control. Holland's landmark paper using radiologic-pathologic correlation of mastectomy specimens, whilst finding residual foci beyond the boundaries of cosmetically acceptable resection margins, also found most of the residual tumour relatively close to the index mass. There is a known dose-response for control of breast cancer. Kurtz reported a doubling of the longterm recurrence rate when the dose to the tumour bed was less than 75 Gy or delivered at less than 8 Gy per week from 15% to 30% using telecesium following lumpectomy. Treating the entire breast to doses above 50 to 54 Gy in 5 weeks is associated with significantly worse cosmesis, hence the common use of a boost. There are as yet no controlled comparisons published however Beadle reported a 50% increase in the rates of poor cosmesis when a boost was employed. Borger has demonstrated that the risk of fibrosis increases fourfold with every 100 cm3 increase in boost volume. Accurate localisation of the tumour bed for boost delivery is difficult in the absence of radioopaque clips (uncommonly employed by our referral base). The use of electrons to deliver the boost has been reported to decrease the cosmetic outcome compared to I192 because of telangiectasia, although this is controversial with other reports indicating superior results with electrons, which is the modality available at St George and Wollongong. The latter avoids hospitalisation. There is at least one other randomised multicentre study being conducted testing the value of a boost by the EORTC in Europe but no results are yet available. Comparisons: Patients will be stratified by chemotherapy (none, AC, non-AC) and within the non-AC arm will be randomised in respect to timing (pre, sandwich, concurrent) of radiotherapy. Randomisation to treatment will be - boost (45Gy 25# + 16Gy 8#) or no boost (50Gy 25#).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Neoplasm recurrence, local, Radiotherapy dosage, Cosmesis, Mastectomy, segmental

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
680 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Radiotherapy (boost versus no boost)
Primary Outcome Measure Information:
Title
Local failure of breast cancer at 72 month median follow-up and 10 year median follow-up for final analysis
Secondary Outcome Measure Information:
Title
Local control translating to survival over 10 year median follow-up
Title
Quality of life at yearly intervals with reference to baseline
Title
Breast cosmesis - patient assessment and photos

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Associate Prof. Peter H Graham, MBBS FRANZCR
Phone
+61 29350 3912
Email
GrahamP@sesahs.nsw.gov.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Associate Prof. Peter H Graham, MBBS FRANZCR
Organizational Affiliation
Cancer Care Centre, St George Hospital, Sydney, Australia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Geoff Delaney, MBBS FRANZCR
Organizational Affiliation
Liverpool Hospital, Sydney, Australia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Chris Fox, MBBS FRANZCR
Organizational Affiliation
Wollongong Hospital, Wollongong, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liverpool Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Geoff Delaney, MBBS FRANZCR
Phone
+61 29828 5276
Email
Geoff.Delaney@swsahs.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Dr Geoff Delaney, MBBS FRANZCR
Facility Name
Cancer Care Centre, St George Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Associate Prof. Peter H Graham, MBBS FRANZCR
Phone
+61 29350 3912
Email
GrahamP@sesahs.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Associate Prof. Peter H Graham, MBBS FRANZCR
Facility Name
Wollongong Hospital
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Chris Fox, MBBS FRANZCR
Phone
+61 24222 5200
First Name & Middle Initial & Last Name & Degree
Dr Chris Fox, MBBS FRANZCR

12. IPD Sharing Statement

Citations:
PubMed Identifier
25023199
Citation
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.
Results Reference
derived
PubMed Identifier
23580069
Citation
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.
Results Reference
derived
PubMed Identifier
21255943
Citation
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.
Results Reference
derived
PubMed Identifier
19720911
Citation
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.
Results Reference
derived

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Boost Use in Breast Conservation Radiotherapy

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