Ignite Creation Date:
2024-05-05 @ 10:02 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01014715
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2009-11-16
Brief Title:
Preoperative Accelerated Partial Breast Irradiation APBI for Women With Stage I and Select IIA Breast Cancer
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Preoperative Accelerated Partial Breast Irradiation APBI for Women With Stage I and Select IIA Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-09
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:
GCC 0919
Brief Summary:
The purpose of this study is to examine the feasibility to deliver PBI before the lumpectomy is performed By administering the PBI before the lumpectomy a smaller volume of breast tissue may be exposed to radiation The PBI method used in this study is 3D three dimensional conformal external beam irradiation 3D-conformal external beam irradiation uses an x-ray beam to deliver the radiation dose Approximately 3 weeks after completion of the PBI the cancer will be surgically removed
This study will learn about the good and bad effects of 3D-conformal external beam irradiation PBI when given before the cancer has been removed by lumpectomy The study will also learn about the feelings women have about how their breast looks after PBI and surgery
This study will learn about the good and bad effects of 3D-conformal external beam irradiation PBI when given before the cancer has been removed by lumpectomy The study will also learn about the feelings women have about how their breast looks after PBI and surgery
Detailed Description:
This study will evaluate the feasibility cosmetic results complication rates and local control rate of 3D-CRT confined to the region of the lumpectomy cavity for patients with Stage I and IIa less than or equal to 3 cm carcinoma of the breast non-lobular histology treated with APBI using 3D-CRT before lumpectomy For selected patients with Stage I and II breast carcinoma 3D-CRT delivered to the primary tumor preoperatively is technically reproducible with acceptable complication rates Cosmetic results after partial breast irradiation before lumpectomy will be comparable to that obtained after whole breast external beam radiation therapy The local tumor control rate in the breast after partial breast irradiation therapy followed by lumpectomy will be comparable to that of conventional external beam radiation therapy with less inconvenience and potentially less cost to the patient given the selection criteria which minimize the risk of clinically significant multicentric or extensive residual carcinoma following lumpectomy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GCC 0919 | None | None | None |