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

Shayna Showalter, MD

Status: Completed

Conditions: Breast Cancer

Treatments: Radiation: Intra-operative Radiation Therapy (IORT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01988870

17091

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Intra-operative Radiation Therapy (IORT)

Experimental group

Description:

Following breast conserving surgery, a CT-based plan will be prepared to deliver highly conformal IORT and the treatment will be administered.

Treatment:

Radiation: Intra-operative Radiation Therapy (IORT)