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| Sponsored by: |
St George Hospital, Australia |
|---|---|
| Information provided by: | St George Hospital, Australia |
| ClinicalTrials.gov Identifier: | NCT00138814 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomised Comparison of Breast Conservation With or Without Lumpectomy Radiotherapy Boost |
| Estimated Enrollment: | 680 |
| Study Start Date: | January 1997 |
| Estimated Study Completion Date: | December 2015 |
A boost dose of radiation is commonly but not universally employed in breast conservation techniques.
The potential disadvantages when a boost is employed include:
The potential advantages of a boost are the following:
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Associate Prof. Peter H Graham, MBBS FRANZCR | +61 29350 3912 | GrahamP@sesahs.nsw.gov.au |
| 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 | |
| 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
| Study ID Numbers: | 96/84 Graham |
| Study First Received: | August 29, 2005 |
| Last Updated: | December 14, 2005 |
| ClinicalTrials.gov Identifier: | NCT00138814 History of Changes |
| Health Authority: | Australia: Human Research Ethics Committee |
|
Neoplasm recurrence, local Radiotherapy dosage Cosmesis Mastectomy, segmental |
|
Skin Diseases Breast Neoplasms Neoplasm Recurrence, Local Breast Diseases Recurrence |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |