Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT02266602
Status:
COMPLETED
Last Update Posted:
2019-04-26
First Post:
2014-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoperative Radiation Therapy in Early Stage Breast Cancer
Sponsor:
Benaroya Research Institute
Organization:
Study Overview
Official Title:
Intra-Operative Radiotherapy After Breast Conserving Therapy in the Treatment of in Situ and Early Stage Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-04
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:
IORTBreast
Brief Summary:
Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and early stage breast cancer.
Detailed Description:
The purpose of this clinical study is to assess the effectiveness of IORT, using an electronic brachytherapy system, in patients with limited-volume in situ and early stage breast cancer, with endpoints of:
* Local recurrence in early stage breast cancer patients treated with IORT.
* Toxicity associated with IORT.
* Long-term disease-specific and overall survival
* Cosmetic results using the Harvard Scale at start and follow-up periods in patients treated with IORT.
* Quality of life in patients treated with IORT.
* Health care costs associated with IORT.
* Local recurrence in early stage breast cancer patients treated with IORT.
* Toxicity associated with IORT.
* Long-term disease-specific and overall survival
* Cosmetic results using the Harvard Scale at start and follow-up periods in patients treated with IORT.
* Quality of life in patients treated with IORT.
* Health care costs associated with IORT.
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?: