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

January 23, 2023 updated by: Shayna Showalter, MD

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

358

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack Meridian Health - John Theurer Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19147
        • Thomas Jefferson University
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of Local Breast Tumor Recurrence
Time Frame: Up to 60 Months After Treatment
Up to 60 Months After Treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Ipsilateral Breast Tumor (Not Local) Recurrence
Time Frame: Up to 60 Months After Treatment
Up to 60 Months After Treatment
Rate of Distant Recurrence of Breast Cancer
Time Frame: Up to 60 Months After Treatment
Up to 60 Months After Treatment
Cancer Specific-Survival and Overall Survival Response Rate
Time Frame: Minimum of 60 Months After Treatment
Minimum of 60 Months After Treatment
Changes in Reported Patient and Physician Cosmetic Descriptions
Time Frame: Up to 60 Months After Treatment
Up to 60 Months After Treatment
Comparison of Pre-and Post Pathology Stratum
Time Frame: Up to 60 Months After Treatment
Up to 60 Months After Treatment
Changes in Patient-Reported Quality of Life
Time Frame: Up to 60 Months After Treatment
Up to 60 Months After Treatment
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.
24 Months After Treatment
Changes of Radiographic Breast Appearance
Time Frame: Up to 60 Months After Treatment
Up to 60 Months After Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shayna Showalter, MD

Investigators

  • Principal Investigator: Shayna Showalter, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

September 1, 2027

Study Completion (Anticipated)

September 1, 2027

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18004
  • IORT2 (Other Identifier: University of Virginia)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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