Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT05464667
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2022-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preoperative Irradiation for Stage I Breast Cancer
Sponsor:
Parul Barry
Organization:
Study Overview
Official Title:
Preoperative Irradiation for Stage I Breast Cancer: A Phase IB Study
Status:
RECRUITING
Status Verified Date:
2025-11
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 novel use of preoperative RT will have broad implications for breast cancer patients, most of whom present with early-stage disease. In the era of reduced chemotherapy delivery, preoperative RT will allow oncologists to assess radiologic and biologic tumor response and correlate it to outcomes. Underutilization of RT negatively affects mortality. This trial aims to further evaluate pre-operative radiation therapy in patients with early stage, biologically favorable breast cancer, with improved access to RT.
Detailed Description:
This trial is a dose escalation study where we will evaluate preoperative dose-escalated RT in four cohorts and determine the maximum tolerated dose (MTD)In the first cohort, patients will be assigned to receive the standard dose of 30 Gy in 5 fractions to the planning target volume (PTV) and 30 GY in 5 fractions to the gross target volume (GTV). In the subsequent cohorts patients will receive 30 Gy in 5 fractions to the PTV with dose-escalation of the GTV to 35 Gy, 40 Gy, and 50 Gy respectively. An interim analysis will be performed after 40 Gy to assess toxicity.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: