Breast Cancer Clinical Trial

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

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.

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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

Study is for people with:

Breast Cancer

Estimated Enrollment:

28

Study ID:

NCT01988870

Recruitment Status:

Completed

Sponsor:

Shayna Showalter, MD

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There is 1 Location for this study

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University of Virginia Health System
Charlottesville Virginia, 22908, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

28

Study ID:

NCT01988870

Recruitment Status:

Completed

Sponsor:


Shayna Showalter, MD

How clear is this clinincal trial information?

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