Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165256
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-06
First Post:
2005-09-09
Brief Title:
Wide Excision Alone as Treatment for Ductal Carcinoma in Situ of The Breast
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Wide Excision Alone for DCIS-Grades 1 and 2
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
None
Brief Summary:
The purpose of this study is to determine if wide excision surgical removal alone is adequate treatment for small grade 1 or 2 ductal carcinoma in situ DCIS of the breast
Detailed Description:
Patients with DCIS are usually treated with the combination of breast-conserving surgery and radiation therapy or breast-conserving surgery alone The purpose of this study is to evaluate whether localized low- or intermediate-grade DCIS diagnosed with modern mammography and careful pathologic evaluation could be treated with wide excision alone omission of radiation therapy and result in acceptably low local recurrence rates
Follow-up consists of physical examinations at least every 6 months by the surgeon or radiation oncologist Mammograms of the affected breast will be obtained every 6 months for 5 years and then annually Mammograms of the unaffected breast will be performed annually
Follow-up consists of physical examinations at least every 6 months by the surgeon or radiation oncologist Mammograms of the affected breast will be obtained every 6 months for 5 years and then annually Mammograms of the unaffected breast will be performed annually
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