Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165243
Status:
COMPLETED
Last Update Posted:
2017-06-07
First Post:
2005-09-09
Brief Title:
Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Tangential Radiation Therapy Without Axillary Dissection in Early-Stage Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-06
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 evaluate whether treatment to the axilla area under the arm can be safely minimized by omitting axillary surgery and full axillary radiation therapy and replacing it with radiation therapy to the breast and lower axilla
Detailed Description:
Patients will have undergone conservative breast surgery without axillary dissection prior to enrollment in this study
Patients will receive radiation therapy to the breast including the lowest axillary lymph nodes over a period of 6 12 weeks
No radiation will be specifically directed toward the upper axilla or supraclavicular lymph nodes
Patients will also receive 5 years of tamoxifen or another type of hormone therapy determined by the medical oncologist
Follow-up visits will occur every 6 months and mammograms every 12 months
Patients will receive radiation therapy to the breast including the lowest axillary lymph nodes over a period of 6 12 weeks
No radiation will be specifically directed toward the upper axilla or supraclavicular lymph nodes
Patients will also receive 5 years of tamoxifen or another type of hormone therapy determined by the medical oncologist
Follow-up visits will occur every 6 months and mammograms every 12 months
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