IORT (Intra-operative Radiation Therapy) in Early Stage Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 11/23/2016 |
| Start Date: | December 2013 |
| End Date: | November 2015 |
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
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.
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.
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
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University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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