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

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ClinicalTrials.gov Identifier: NCT01988870
Recruitment Status : Completed
First Posted : November 20, 2013
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Shayna Showalter, MD, University of Virginia

Tracking Information
First Submitted Date  ICMJE November 13, 2013
First Posted Date  ICMJE November 20, 2013
Last Update Posted Date November 22, 2016
Study Start Date  ICMJE December 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01988870 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2013)
  • IORT treatment parameters [ Time Frame: up to 6 hours ]
    Gather preliminary data on planning time, total radiation delivery time, total procedure time, and dosimetry
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IORT (Intra-operative Radiation Therapy) in Early Stage Breast Cancer
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Radiation: Intra-operative Radiation Therapy (IORT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2016)
28
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2013)
30
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01988870
Other Study ID Numbers  ICMJE 17091
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shayna Showalter, MD, University of Virginia
Study Sponsor  ICMJE Shayna Showalter, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shayna Showalter, MD University of Virginia
PRS Account University of Virginia
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP