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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01988870
First Posted: November 20, 2013
Last Update Posted: November 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shayna Showalter, MD, University of Virginia
  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: Intervention Model: Single Group Assignment
Masking: None (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 Shayna Showalter, MD, University of Virginia:

Primary Outcome Measures:
  • IORT (Intra-operative Radiation Therapy) treatment interval [ Time Frame: 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 [ Time Frame: Up to 6 months following treatment ]

Secondary Outcome Measures:
  • IORT treatment parameters [ Time Frame: up to 6 hours ]
    Gather preliminary data on planning time

  • Cosmetic Outcome [ Time Frame: 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

  • Quality of life assessment [ Time Frame: Up to 6 months following treatment ]
    Patients will complete a breast cancer specific quality of life survey

  • IORT treatment parameters [ Time Frame: upto 6 hours ]
    gather preliminary data on total radiation delivery time

  • IORT treatment parameters [ Time Frame: upto 6 hours ]
    Gather preliminary data on total procedure time

  • IORT treatment parameters [ Time Frame: upto 6 hours ]
    Gather preliminary data on dosimetry


Enrollment: 28
Study Start Date: December 2013
Study Completion Date: November 2015
Primary Completion Date: April 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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988870


Locations
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Shayna Showalter, MD
Investigators
Principal Investigator: Shayna Showalter, MD University of Virginia
  More Information

Responsible Party: Shayna Showalter, MD, Assistant Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT01988870     History of Changes
Other Study ID Numbers: 17091
First Submitted: November 13, 2013
First Posted: November 20, 2013
Last Update Posted: November 22, 2016
Last Verified: November 2016

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


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