Working… Menu

Efficacy of IORT With CT-Guided HDR Brachytherapy for Treatment of Breast Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02400658
Recruitment Status : Recruiting
First Posted : March 27, 2015
Last Update Posted : July 19, 2019
Information provided by (Responsible Party):
Shayna Showalter, MD, University of Virginia

Brief Summary:
The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat early-stage breast cancer at the time of surgery.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: IORT with CT-Guided HDR Brachytherapy Not Applicable

Detailed Description:
This is a prospective single-arm phase II study designed to study the efficacy of high dose rate (HDR) brachytherapy with CT-imaging, single-fraction intraoperative radiation therapy (IORT). The study will accrue patients with early-stage breast cancer who will be treated with breast-conserving surgery (BCS). The main clinical eligibility criterion is based on suitability for accelerated partial breast irradiation. Patients may be eligible prior to receiving BCS or within 30 days of receiving BCS. Eligible patients that will undergo BCS will receive surgery according to the standard clinical practice in the Brachytherapy Suite in the Emily Couric Clinical Cancer Center. Patients that have already undergone BCS must meet all other eligibility criteria and are able to be treated with IORT within 30 days of their breast surgery. Eligible subjects will undergo a lumpectomy or re-excision lumpectomy according the standard clinical practice. Immediately following lumpectomy, the breast HDR brachytherapy applicator will be placed and CT imaging will be performed for treatment planning. After HDR brachytherapy is delivered, the applicator will be removed, and the breast surgeon will complete the skin closure. Although the ultimate goal of the study is to determine 5-year ipsilateral breast tumor recurrence (IBTR), all efforts will be made to follow the patients until death.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 358 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Single-Arm Phase II Study To Investigate The Efficacy Of Single-Fraction Intraoperative Radiation Treatment Using A Multi-Lumen Balloon Applicator And In-Room CT Imaging For The Treatment Of Early-Stage Breast Cancer
Study Start Date : March 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: IORT with CT-Guided HDR Brachytherapy
Patients will receive IORT with CT-guided HDR brachytherapy at the time of breast surgery.
Device: IORT with CT-Guided HDR Brachytherapy
This therapy targets the cancer cells directly, reducing the volume of breast tissue exposed to the radiation and the risks involved with the radiation. CT imaging will be used via a multichannel/multi-dwell balloon catheter to better sculpt the cancer away from the heart, skin, and ribs.
Other Names:
  • Surgery
  • Breast Lumpectomy

Primary Outcome Measures :
  1. Rate of Local Breast Tumor Recurrence [ Time Frame: Up to 60 Months After Treatment ]

Secondary Outcome Measures :
  1. Rate of Ipsilateral Breast Tumor (Not Local) Recurrence [ Time Frame: Up to 60 Months After Treatment ]
  2. Rate of Distant Recurrence of Breast Cancer [ Time Frame: Up to 60 Months After Treatment ]
  3. Cancer Specific-Survival and Overall Survival Response Rate [ Time Frame: Minimum of 60 Months After Treatment ]
  4. Changes in Reported Patient and Physician Cosmetic Descriptions [ Time Frame: Up to 60 Months After Treatment ]
  5. Comparison of Pre-and Post Pathology Stratum [ Time Frame: Up to 60 Months After Treatment ]
  6. Changes in Patient-Reported Quality of Life [ Time Frame: Up to 60 Months After Treatment ]
  7. Number of Participants with Adverse Events [ Time Frame: 24 Months After Treatment ]
    Safety and toxicity of treatment will be determined with the Common Toxicity Criteria for Adverse Effects.

  8. Changes of Radiographic Breast Appearance [ Time Frame: Up to 60 Months After Treatment ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient has elected breast conserving surgery or whole breast irradiation treatment for early-stage breast cancer.
  2. Tumor size must be less than or equal to 3 cm.
  3. Patient is 45 years of age or older.

Exclusion Criteria:

  1. Male patients.
  2. Pregnant patients.
  3. Breast cancer that involves the skin or chest wall.
  4. History of ipsilateral breast cancer.
  5. Multicentric breast cancer in the ipsilateral breast.
  6. Known BRCA gene mutation.
  7. Patient with nodal disease.
  8. Patient is undergoing initial medical treatment (hormone or chemotherapy) to reduce tumor size.
  9. Patient with breast implants (does not include patients having implants AFTER intra-operative radiotherapy).

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 identifier (NCT number): NCT02400658

Layout table for location contacts
Contact: Steve Fowler 434-243-4730

Layout table for location information
United States, New Jersey
Hackensack Meridian Health - John Theurer Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Lori Cappello    551-996-5098   
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19147
Contact: Noelle Sowers, RN    215-955-0087   
Principal Investigator: Adam Berger, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Dena Snyder, RN    434-243-6899   
Contact: Shayna Showalter, MD    434-924-9479   
Principal Investigator: Shayna Showalter, MD         
Sponsors and Collaborators
Shayna Showalter, MD
Layout table for investigator information
Principal Investigator: Shayna Showalter University of Virginia
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Shayna Showalter, MD, Assistant Professor of Medicine, University of Virginia Identifier: NCT02400658    
Other Study ID Numbers: 18004
IORT2 ( Other Identifier: University of Virginia )
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Keywords provided by Shayna Showalter, MD, University of Virginia:
breast cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases