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

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

Tracking Information

• First Submitted Date: November 13, 2013
• First Posted Date: November 20, 2013
• Last Update Posted Date: November 22, 2016
• Study Start Date: December 2013
• Actual Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: IORT (Intra-operative Radiation Therapy) in Early Stage Breast Cancer
• 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

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Breast Cancer

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.

Study Arms

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 1, 2016): 28
• Original Estimated Enrollment (submitted: November 13, 2013): 30
• Actual Study Completion Date: November 2015
• Actual Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01988870
• Other Study ID Numbers: 17091
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Shayna Showalter, MD, University of Virginia
• Study Sponsor: Shayna Showalter, MD
• Collaborators: Not Provided

Investigators

• Principal Investigator: Shayna Showalter, MD; University of Virginia

• PRS Account: University of Virginia
• Verification Date: November 2016