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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- IORT (Intra-operative Radiation Therapy) treatment interval
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
- •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
Arms & Interventions
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.
Intervention: Intra-operative Radiation Therapy (IORT) (Radiation)
Outcomes
Primary Outcomes
IORT (Intra-operative Radiation Therapy) treatment interval
Time Frame: 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
Time Frame: Up to 6 months following treatment
Secondary Outcomes
- IORT treatment parameters(upto 6 hours)
- Quality of life assessment(Up to 6 months following treatment)
- Cosmetic Outcome(Up to 6 months following treatment)
- IORT treatment parameters(up to 6 hours)
Investigators
Shayna Showalter, MD
Assistant Professor
University of Virginia