Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT02685332
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-20
First Post:
2016-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Dose Escalation of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation Early Stage Breast CA
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Phase I Dose Escalation Trial of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation (SB-PBI) For Early Stage Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
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:
Radiation, Stereotactic Body Radiation Therapy.
Detailed Description:
In this protocol, we plan to use the uniqueness of the Cyberknife system to deliver an adjuvant single fraction radiation dose. We anticipate that this radiation deliver system will reduce toxicity and improve cosmesis. Extrapolating from an intra-operative body of work, this Phase I study will attempt to achieve a non-invasive low toxicity profile and maintain good to excellent cosmesis. In this effort, the Cyberknife system will be used to achieve high conformality and dose gradient.
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?:
False
Is an FDA AA801 Violation?: