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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Radiation: Intra-operative Radiation Therapy (IORT)

• Registration Number: NCT01988870
• Lead Sponsor: Shayna Showalter, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-20
• Study Start: 2013-12
• Primary Completion: 2015-04
• Study Completion: 2015-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intra-operative Radiation Therapy (IORT)	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.

Primary Outcome Measures

Name	Time	Method
IORT (Intra-operative Radiation Therapy) treatment interval	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	Up to 6 months following treatment

Secondary Outcome Measures

Name	Time	Method
Quality of life assessment	Up to 6 months following treatment	Patients will complete a breast cancer specific quality of life survey
Cosmetic Outcome	Up to 6 months following treatment	Digital photographs will be taken and used to assess breast characteristics (i.e. color/pigmentation, size, shape) and evaluated for cosmetic outcomes
IORT treatment parameters	upto 6 hours	Gather preliminary data on dosimetry

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States