Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery
NCT01570998 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1259
Last updated 2026-03-18
Summary
This phase IV trial studies the side effects of intraoperative radiation therapy and how well it works in treating patients with breast cancer undergoing breast-conserving surgery. Delivering radiation one time to the area where the tumor was removed while the patient is still in the operating room may kill any residual tumor cells and may be as effective as standard radiation therapy in patients with early stage breast cancer.
Conditions
- Stage IA Breast Cancer
- Stage IIA Breast Cancer
Interventions
- RADIATION
-
Intraoperative Radiation Therapy
Undergo IORT
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
Sponsors & Collaborators
-
Carl Zeiss Meditec AG
collaborator INDUSTRY -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Michael Alvarado, MD · University of California, San Francisco
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-05-18
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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