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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988870
• Other study ID #: 17091
• Status: Completed
• Phase: N/A
• First received: November 13, 2013
• Last updated: November 21, 2016
• Start date: December 2013
• Est. completion date: November 2015

Study information

• Verified date: November 2016
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Shayna Showalter, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IORT (Intra-operative Radiation Therapy) treatment interval	Evaluation of the time from the acquisition of the initial CT-on-rails until the time at which IORT is complete	90 minutes or less	No
Primary	Overall incidence of adverse events and major toxicities		Up to 6 months following treatment	Yes
Secondary	IORT treatment parameters	Gather preliminary data on planning time	up to 6 hours	No
Secondary	Cosmetic Outcome	Digital photographs will be taken and used to assess breast characteristics (i.e. color/pigmentation, size, shape) and evaluated for cosmetic outcomes	Up to 6 months following treatment	No
Secondary	Quality of life assessment	Patients will complete a breast cancer specific quality of life survey	Up to 6 months following treatment	No
Secondary	IORT treatment parameters	gather preliminary data on total radiation delivery time	upto 6 hours	No
Secondary	IORT treatment parameters	Gather preliminary data on total procedure time	upto 6 hours	No
Secondary	IORT treatment parameters	Gather preliminary data on dosimetry	upto 6 hours	No