Clinical Trial: Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT) As A Single, Full Dose Partial Breast Irradiation For Early Stage, Node Negative, Invasive Breast Cancer

Brief Summary: The overall objective of this study is to determine the feasibility and tolerability of single dose Intraoperative Electron Radiation Treatment ("IOERT") as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer.

Detailed Summary:

Evaluate local and distant recurrence rates and cosmetic outcomes. Both clinical evaluation of cosmetic outcome by the Surgeon, and subjective impression of cosmetic outcome by the patient, are evaluated using questionnaire.

Local recurrence is evaluated under the same imaging protocol used for Whole breast radiation.


Sponsor: Advocate Health Care

Current Primary Outcome: To evaluate the overall incidence of local and distance recurrence rates. [ Time Frame: 5 years ]

Subjects will be followed at one month, six months, and then once every six months until five years and then yearly up to 10 years.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Advocate Health Care

Dates:
Date Received: September 25, 2013
Date Started: May 2013
Date Completion: July 2023
Last Updated: November 6, 2016
Last Verified: November 2016