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

NCT ID: NCT01988870

Last Updated: 2016-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-11-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intra-operative Radiation Therapy (IORT)

Intervention Type: RADIATION

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.

Interventions

Intra-operative Radiation Therapy (IORT)

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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shayna Showalter, MD

OTHER

Sponsor Role: lead

Responsible Party

Shayna Showalter, MD

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shayna Showalter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Health System

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

17091

Identifier Type: -

Identifier Source: org_study_id