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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by University of Virginia
Sponsor:
Information provided by (Responsible Party):
Shayna Showalter, MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT01988870
First received: November 13, 2013
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Radiation: Intra-operative Radiation Therapy (IORT)

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

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • IORT (Intra-operative Radiation Therapy) treatment interval [ Time Frame: 90 minutes or less ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 6 months following treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • IORT treatment parameters [ Time Frame: up to 6 hours ] [ Designated as safety issue: No ]
    Gather preliminary data on planning time

  • Cosmetic Outcome [ Time Frame: Up to 6 months following treatment ] [ Designated as safety issue: No ]
    Digital photographs will be taken and used to assess breast characteristics (i.e. color/pigmentation, size, shape) and evaluated for cosmetic outcomes

  • Quality of life assessment [ Time Frame: Up to 6 months following treatment ] [ Designated as safety issue: No ]
    Patients will complete a breast cancer specific quality of life survey

  • IORT treatment parameters [ Time Frame: upto 6 hours ] [ Designated as safety issue: No ]
    gather preliminary data on total radiation delivery time

  • IORT treatment parameters [ Time Frame: upto 6 hours ] [ Designated as safety issue: No ]
    Gather preliminary data on total procedure time

  • IORT treatment parameters [ Time Frame: upto 6 hours ] [ Designated as safety issue: No ]
    Gather preliminary data on dosimetry


Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988870

Contacts
Contact: Parchayi Dalal, MPH, CCRC 434-243-7231 pd9d@virginia.edu
Contact: Gretchen Watkins, BA, CIP 434-243-1619 gmw7h@virginia.edu

Locations
United States, Virginia
University of Virginia Health System Not yet recruiting
Charlottesville, Virginia, United States, 22908
Contact: Parchayi Dalal, MPH, CCRC    434-243-7231    pd9d@virginia.edu   
Principal Investigator: Shayna Showalter, MD         
Sub-Investigator: Timothy N Showalter, MD         
Sub-Investigator: Monica Morris, MD         
Sub-Investigator: Paul Read, MD, PhD         
Sub-Investigator: David Brenin, MD         
Sub-Investigator: Anneke Schroen, MD         
Sponsors and Collaborators
Shayna Showalter, MD
Investigators
Principal Investigator: Shayna Showalter, MD University of Virginia
  More Information

No publications provided

Responsible Party: Shayna Showalter, MD, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT01988870     History of Changes
Other Study ID Numbers: 17091
Study First Received: November 13, 2013
Last Updated: November 20, 2013
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014