Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00185744
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-24
First Post:
2005-09-12
Brief Title:
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
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:
To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose intracavitary brachytherapy with the MammoSite device over 5 days partial breast 3-D CRT in 5 days or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy The study will measure both short and long-term complications of radiation treatment short and long-term breast cosmesis local rates of in-breast cancer recurrence regional recurrences distant metastases and overall survival
Detailed Description:
None
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 |
|---|---|---|---|
| IRB-13807 | OTHER | Stanford IRB | None |
| 78466 | OTHER | None | None |
| BRSNSTU0003 | OTHER | None | None |
| NCT00185744 | None | None | None |