NCT01960803

Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 50 Years – 95 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Invasive Ductal Breast Cancer
• Carcinoma Breast Stage I

Interventions

Type	Name	Description
RADIATION	Intraoperative Electron Radiotherapy	Intraoperative Electron Radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure.

Timeline

• Start date: 2013-05-01
• Primary completion: 2019-06-03
• Completion: 2019-07-05
• First posted: 2013-10-11
• Last updated: 2024-10-04

Locations

1 site across 1 country: United States