IORT (Intra-operative Radiation Therapy) in Early Stage Breast Cancer

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Radiation: Intra-operative Radiation Therapy (IORT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 50 years of age of older Patient has elected breast conserving surgical treatment for early-stage breast cancer Patient meets American Society for Therapeutic Radiation Oncology (ASTRO) criteria for a suitable or cautionary patient Life expectancy of more than 2 years Tumor size 4cm or less Women of childbearing potential must agree to use adequate contraception Exclusion Criteria: Male Pregnant or nursing Any contraindication to radiotherapy Breast cancer that involves skin or chest wall, bilateral breast cancer or history of breast cancer in ipsilateral breast Patient meets any of the ASTRO criteria for an unsuitable patient Patient requires chemotherapy within two weeks of IORT Breast implants A serious uncontrolled medical disorder Significant history of uncontrolled cardiac disease or CNS disease

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intra-operative Radiation Therapy (IORT)<br>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)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IORT (Intra-operative Radiation Therapy) treatment interval | Evaluation of the time from the acquisition of the initial CT-on-rails until the time at which IORT is complete | 90 minutes or less | 
| Overall incidence of adverse events and major toxicities |  | Up to 6 months following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IORT treatment parameters | Gather preliminary data on planning time | up to 6 hours | 
| Cosmetic Outcome | Digital photographs will be taken and used to assess breast characteristics (i.e. color/pigmentation, size, shape) and evaluated for cosmetic outcomes | Up to 6 months following treatment | 
| Quality of life assessment | Patients will complete a breast cancer specific quality of life survey | Up to 6 months following treatment | 
| IORT treatment parameters | gather preliminary data on total radiation delivery time | upto 6 hours | 
| IORT treatment parameters | Gather preliminary data on total procedure time | upto 6 hours | 
| IORT treatment parameters | Gather preliminary data on dosimetry | upto 6 hours |