Boost Use in Breast Conservation Radiotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2005 by St George Hospital, Australia
Sponsor:
Information provided by:
St George Hospital, Australia
ClinicalTrials.gov Identifier:
NCT00138814
First received: August 29, 2005
Last updated: December 14, 2005
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Procedure: Radiotherapy (boost versus no boost)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Comparison of Breast Conservation With or Without Lumpectomy Radiotherapy Boost

Resource links provided by NLM:


Further study details as provided by St George Hospital, Australia:

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

Estimated Enrollment: 680
Study Start Date: January 1997
Estimated Study Completion Date: December 2015
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#).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138814

Contacts
Contact: Associate Prof. Peter H Graham, MBBS FRANZCR +61 29350 3912 GrahamP@sesahs.nsw.gov.au

Locations
Australia, New South Wales
Cancer Care Centre, St George Hospital Recruiting
Sydney, New South Wales, Australia, 2217
Contact: Associate Prof. Peter H Graham, MBBS FRANZCR    +61 29350 3912    GrahamP@sesahs.nsw.gov.au   
Principal Investigator: Associate Prof. Peter H Graham, MBBS FRANZCR         
Liverpool Hospital Recruiting
Sydney, New South Wales, Australia, 2170
Contact: Dr Geoff Delaney, MBBS FRANZCR    +61 29828 5276    Geoff.Delaney@swsahs.nsw.gov.au   
Principal Investigator: Dr Geoff Delaney, MBBS FRANZCR         
Wollongong Hospital Recruiting
Wollongong, New South Wales, Australia, 2500
Contact: Dr Chris Fox, MBBS FRANZCR    +61 24222 5200      
Principal Investigator: Dr Chris Fox, MBBS FRANZCR         
Sponsors and Collaborators
St George Hospital, Australia
Investigators
Principal Investigator: Associate Prof. Peter H Graham, MBBS FRANZCR Cancer Care Centre, St George Hospital, Sydney, Australia
Principal Investigator: Dr Geoff Delaney, MBBS FRANZCR Liverpool Hospital, Sydney, Australia
Principal Investigator: Dr Chris Fox, MBBS FRANZCR Wollongong Hospital, Wollongong, Australia
  More Information

No publications provided by St George Hospital, Australia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00138814     History of Changes
Other Study ID Numbers: 96/84 Graham
Study First Received: August 29, 2005
Last Updated: December 14, 2005
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by St George Hospital, Australia:
Neoplasm recurrence, local
Radiotherapy dosage
Cosmesis
Mastectomy, segmental

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014