Boost Use in Breast Conservation Radiotherapy

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00138814
• Other study ID #: 96/84 Graham
• Status: Recruiting
• Phase: Phase 3
• First received: August 29, 2005
• Last updated: December 14, 2005
• Start date: January 1997
• Est. completion date: December 2015

Study information

• Verified date: September 2005
• Source: St George Hospital, Australia
• Contact: Associate Prof. Peter H Graham, MBBS FRANZCR
• Phone: +61 29350 3912
• Email: GrahamP[@]sesahs.nsw.gov.au
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical 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.

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#).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 680
• Est. completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Procedure:
• Radiotherapy (boost versus no boost)

Locations

Country	Name	City	State
Australia	Cancer Care Centre, St George Hospital	Sydney	New South Wales
Australia	Liverpool Hospital	Sydney	New South Wales
Australia	Wollongong Hospital	Wollongong	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
St George Hospital, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local failure of breast cancer at 72 month median follow-up and 10 year median follow-up for final analysis
Secondary	Local control translating to survival over 10 year median follow-up
Secondary	Quality of life at yearly intervals with reference to baseline
Secondary	Breast cosmesis - patient assessment and photos