Breast Cancer
Conditions
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.
Interventions
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.
Sponsors
Shayna Showalter, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IORT (Intra-operative Radiation Therapy) treatment interval | 90 minutes or less | 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 | Up to 6 months following treatment | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IORT treatment parameters | up to 6 hours | Gather preliminary data on planning time |
| Cosmetic Outcome | Up to 6 months following treatment | 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 | Up to 6 months following treatment | Patients will complete a breast cancer specific quality of life survey |
Countries
United States
Outcome results
None listed