Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00138814
Status:
UNKNOWN
Last Update Posted:
2005-12-15
First Post:
2005-08-29
Brief Title:
Boost Use in Breast Conservation Radiotherapy
Sponsor:
St George Hospital Australia
Organization:
St George Hospital Australia
Study Overview
Official Title:
A Randomised Comparison of Breast Conservation With or Without Lumpectomy Radiotherapy Boost
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 socialemployment dislocation
Increased complications
Worse cosmesis andor 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 Hollands 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
The potential disadvantages when a boost is employed include
Increased complexity of treatment
Increased duration of treatment
Increased travel socialemployment dislocation
Increased complications
Worse cosmesis andor 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 Hollands 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None