Boost Use in Breast Conservation Radiotherapy

December 14, 2005 updated by: St George Hospital, Australia

A Randomised Comparison of Breast Conservation With or Without Lumpectomy Radiotherapy Boost

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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#).

Study Type

Interventional

Enrollment

680

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2170
        • Recruiting
        • Liverpool Hospital
        • Contact:
        • Principal Investigator:
          • Dr Geoff Delaney, MBBS FRANZCR
      • Sydney, New South Wales, Australia, 2217
        • Recruiting
        • Cancer Care Centre, St George Hospital
        • Contact:
        • Principal Investigator:
          • Associate Prof. Peter H Graham, MBBS FRANZCR
      • Wollongong, New South Wales, Australia, 2500
        • Recruiting
        • Wollongong Hospital
        • Contact:
          • Dr Chris Fox, MBBS FRANZCR
          • Phone Number: +61 24222 5200
        • Principal Investigator:
          • Dr Chris Fox, MBBS FRANZCR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1997

Study Completion

December 1, 2015

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

December 15, 2005

Last Update Submitted That Met QC Criteria

December 14, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 96/84 Graham

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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