IORT (Intra-operative Radiation Therapy) in Early Stage Breast Cancer
The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat breast cancer at the time of surgery.
Traditionally, the recommended treatment for early stage breast cancer is surgery to remove the tumor, followed by whole breast radiation therapy to decrease the chance of recurrence of the cancer. Whole breast radiation involves daily radiation treatments for 4-6 weeks and can be associated with damage to other tissues including the skin. Recent technological advances have made it possible to provide radiation treatment during the breast cancer surgical procedure. This procedure is called intraoperative radiation therapy (IORT). The University of Virginia has a unique IORT system which allows for the inclusion of cutting edge imaging technology into the IORT procedure in order to provide delivery of radiation directly to the needed areas and to avoid radiation to other tissues.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot, Single Arm, Study of the Safety and Feasibility of Single-Fraction Intraoperative Radiation Treatment (IORT) With CT-On-Rails-Guided HDR Brachytherapy for the Treatment of Early-Stage Breast Cancer|
- IORT (Intra-operative Radiation Therapy) treatment interval [ Time Frame: 90 minutes or less ] [ Designated as safety issue: No ]Evaluation of the time from the acquisition of the initial CT-on-rails until the time at which IORT is complete
- Overall incidence of adverse events and major toxicities [ Time Frame: Up to 6 months following treatment ] [ Designated as safety issue: Yes ]
- IORT treatment parameters [ Time Frame: up to 6 hours ] [ Designated as safety issue: No ]Gather preliminary data on planning time
- Cosmetic Outcome [ Time Frame: Up to 6 months following treatment ] [ Designated as safety issue: No ]Digital photographs will be taken and used to assess breast characteristics (i.e. color/pigmentation, size, shape) and evaluated for cosmetic outcomes
- Quality of life assessment [ Time Frame: Up to 6 months following treatment ] [ Designated as safety issue: No ]Patients will complete a breast cancer specific quality of life survey
- IORT treatment parameters [ Time Frame: upto 6 hours ] [ Designated as safety issue: No ]gather preliminary data on total radiation delivery time
- IORT treatment parameters [ Time Frame: upto 6 hours ] [ Designated as safety issue: No ]Gather preliminary data on total procedure time
- IORT treatment parameters [ Time Frame: upto 6 hours ] [ Designated as safety issue: No ]Gather preliminary data on dosimetry
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||October 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Intra-operative Radiation Therapy (IORT)
Following breast conserving surgery, a CT-based plan will be prepared to deliver highly conformal IORT and the treatment will be administered.
Radiation: Intra-operative Radiation Therapy (IORT)
IORT is a form of APBI (accelerated partial breast irradiation) that allows for a high degree of dose homogeneity, exclusion of non-affected structures, and reduction of the volume of breast tissue exposed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01988870
|United States, Virginia|
|University of Virginia Health System|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Shayna Showalter, MD||University of Virginia|