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Breast NeoplasmsPhase 3NCT00138814

Boost Use in Breast Conservation Radiotherapy

A Phase 3 study testing Radiotherapy (boost versus no boost) in people with Breast Neoplasms, run by St George Hospital, Australia at 3 sites in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Radiotherapy (boost versus no boost)
Type of treatment
Surgery or procedure
How many people
680 participants
Where
3 sitesAustralia
Study dates
Jan 1997to Dec 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Associate Prof. Peter H Graham, MBBS FRANZCR contact

+61 29350 3912

GrahamP@sesahs.nsw.gov.au

Australia3 sites, 3 recruiting

  • Liverpool Hospital

    Sydney, New South Wales, 2170

    Dr Geoff Delaney, MBBS FRANZCR, +61 29828 5276, Geoff.Delaney@swsahs.nsw.gov.au

    Dr Geoff Delaney, MBBS FRANZCR

    Recruiting

  • Cancer Care Centre, St George Hospital

    Sydney, New South Wales, 2217

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

    Associate Prof. Peter H Graham, MBBS FRANZCR

    Recruiting

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

    Dr Chris Fox, MBBS FRANZCR, +61 24222 5200

    Dr Chris Fox, MBBS FRANZCR

    Recruiting

Other trials in Australia

About this study

Official title: 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.

Read the 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#).

Being tested
Radiotherapy (boost versus no boost)
Keywords
Neoplasm recurrence, local, Radiotherapy dosage, Cosmesis, Mastectomy, segmental
Medical subject headings
Breast Neoplasms, Neoplasm Recurrence, Local

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiotherapy (boost versus no boost)Procedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

  1. Local control translating to survival over 10 year median follow-up

  2. Quality of life at yearly intervals with reference to baseline

  3. Breast cosmesis - patient assessment and photos

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2005 (estimated)
  2. Study startJan 1997
  3. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
680 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00138814
Sponsor's protocol ID
96/84 Graham
Status last verified
Sep 2005
First submitted
29 Aug 2005
Last updated
15 Dec 2005
Results posted
No

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.

    PubMed 25023199

  • 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.

    PubMed 23580069

  • 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.

    PubMed 21255943

  • 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.

    PubMed 19720911

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radiotherapy (boost versus no boost) in people with Breast Neoplasms, run by St George Hospital, Australia at 3 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Associate Prof. Peter H Graham, MBBS FRANZCR (+61 29350 3912, GrahamP@sesahs.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local failure of breast cancer at 72 month median follow-up and 10 year median follow-up for final analysis. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00138814, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2005.

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