Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-03 @ 6:45 AM
Study NCT ID:
NCT02058667
Status:
WITHDRAWN
Last Update Posted:
2016-11-15
First Post:
2014-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reirradiation With Concurrent Paclitaxel for Breast Cancer
Sponsor:
University of Kentucky
Organization:
Study Overview
Official Title:
A Phase I Study of Twice Weekly Paclitaxel and Radical Re-irradiation Using Helical Tomotherapy for Aggressive Chest Wall Recurrences of Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
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 trial in addition to a dose finding study for concurrent Paclitaxel, will be to establish a treatment algorithm for chest wall reirradiation. A nominal margin of at least 5cm will be used on the protocol and extending it to 7cm. Considering the standard treatment of breast cancer incorporates a cumulative dose of 60Gy, delivering an additional 50.4 Gy followed by a boost should target a total dose of 120 Gy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: