Ignite Creation Date:
2024-05-06 @ 12:59 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01704547
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2012-09-28
Brief Title:
Breast Cup Immobilization Device II GCC 1047
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
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:
BCID II
Brief Summary:
The study is designed to assess the accuracy of patient breast reproducibly using the revised BCID This study would provide data for target verification and quality assurance to eventually allow treatment of breast cancer patients for either a TBB or accelerated partial breast irradiation The BCID is a low-risk device similar to immobilization devices used routinely in radiotherapy for other disease sites
Detailed Description:
Breast conserving therapy BCT has become the standard of care for treating early-stage breast cancers based on six prospective randomized trials with 20 years of follow-up data Fisher During lumpectomy the surgeon removes the tumor and a surrounding rim of normal tissue margin leaving surgical clips to help designate the resection bed Radiation treatment is directed at the whole breast for 5 12 weeks and is generally followed by a 1-2 week boost directed at the lumpectomy site plus a margin of normal breast tissue The benefit of adding the tumor bed boost TBB has been shown in two studies to decrease local failures Romestaig Bartelink
Studies have evaluated the role of radiation following lumpectomy in very select groups which have not been able to define a group who do not benefit from the addition of radiotherapy In the group of patients who received surgery alone 85 of the breast recurrences occurred in the tumor bed Due to these two facts radiotherapy directed only at the tumor bed has been evaluated Treating this smaller tumor volume has allowed higher doses of radiation to be delivered safely shortening the treatment course from 6-7 weeks to one week
Studies have evaluated the role of radiation following lumpectomy in very select groups which have not been able to define a group who do not benefit from the addition of radiotherapy In the group of patients who received surgery alone 85 of the breast recurrences occurred in the tumor bed Due to these two facts radiotherapy directed only at the tumor bed has been evaluated Treating this smaller tumor volume has allowed higher doses of radiation to be delivered safely shortening the treatment course from 6-7 weeks to one week
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