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

Sponsor

Shayna Showalter, MD (Other)

Overall Status

Recruiting

CT.gov ID

NCT02400658

Collaborator

(none)

358

Enrollment

Locations

Arm

102

Duration (Months)

119.3

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2015

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Rate of Local Breast Tumor Recurrence [Up to 60 Months After Treatment]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hackensack Meridian Health - John Theurer Cancer Center	Hackensack	New Jersey	United States	07601
2	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19147
3	University of Virginia	Charlottesville	Virginia	United States	22908