Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer (EXIBT)

Electronic Xoft Intersociety Brachytherapy Trial

PRINCIPAL INVESTIGATORS

• Rakesh Patel, MD- Radiation Oncologist
• Peter Beitsch, MD- Breast Surgeon

REGISTRY DESIGN

• Multicenter, non-randomized, post market registry of intracavitary accelerated partial breast irradiation in appropriately selected patients.

SAMPLE SIZE AND SITES:

• Approximately 400 patients may be enrolled.
• Up to 100 qualified U.S. sites may participate in this registry.

ENDPOINTS:

1. PRIMARY ENDPOINTS

   • Subcutaneous Toxicities - The incidence of signs and symptoms of subcutaneous toxicities will be recorded at the following follow-up visits; at six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
   • Skin Toxicities - Specific toxicities that can result from radiation therapy will be recorded at each follow-up visit. The Common Terminology Criteria for Adverse Events will be used and to be recorded at each follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
   • Cosmetic Outcome - Cosmetic outcome will be recorded at the following follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. Cosmetic outcome will be assessed and graded in two ways:
   • Patient Quality of Life Questionnaire - A Quality of Life Questionnaire (QOL) will be completed at the following visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.

2. SECONDARY ENDPOINTS

   • Local-regional Breast Failure - The secondary efficacy endpoint is ipsilateral breast failure at five (5) years.

   This includes:

   • Ipsilateral recurrence within the initially treated volume. (Within the tumor bed)
   • Ipsilateral recurrence of cancer outside of the initially treated volume. (Elsewhere Failure)

   • Axillary nodal recurrence

     • Survival - to be recorded at each follow-up visit
   • Overall Survival

   • Disease Free Survival

     • Device Performance - to be recorded during the balloon applicator placement and during the course of the radiation treatments:
   • Ability to deliver treatment
   • Axxent System / Balloon Applicator performance
3. TREATMENT DEVICE

The device to be used is the electronic brachytherapy system for the treatment of early stage breast cancer with intracavitary accelerated partial breast irradiation. The device manufacturer is Xoft, Incorporated. All Xoft technology cleared by the FDA for the treatment of early stage breast cancer can be used in this post market data collection registry.

OVERSIGHT COMMITTEE

Representatives from American Brachytherapy Society (ABS), American Society of Breast Surgeons (ASBS), and American College of Radiation Oncology (ACRO)will oversee study management.

Study Overview

• Status: Completed
• Conditions: Carcinoma; Breast Cancer; Ductal Carcinoma in Situ; Lumpectomy
• Intervention / Treatment: Radiation: Electronic Brachytherapy; Radiation: Intracavitary accelerated partial breast irradiation

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35401
      • DCH Cancer Treatment Center
  • California
    • Montebello, California, United States, 90640
      • Beverly Oncology
  • Florida
    • Orange Park, Florida, United States, 32073
      • Florida Radiation Oncology Group
  • Illinois
    • Swansea, Illinois, United States, 62226
      • St Elizabeth's and Memorial Cancer Center
  • Missouri
    • Cape Girardeau, Missouri, United States, 63703
      • Cancer Institute of Cape Girardeau
  • New Jersey
    • Galloway, New Jersey, United States, 08205
      • AtlantiCare Cancer Care Institute
    • Northfield, New Jersey, United States, 08225
      • Nazha Cancer Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Surgical Group / Northpoint Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patient 50 years of age or older
• Estrogen receptor positive
• Tumor size ≤ 3cm
• Tumor histology: invasive carcinoma or DCIS
• Patient is node negative
• Patient has negative surgical margins (NSABP definition, no tumor on ink) after final surgery
• Life expectancy > 5 years

Exclusion Criteria:

• Pregnancy or breast-feeding. (If appropriate, patient must use birth control during the registry.) The need for a pregnancy test is based on the physician's standard practice and will be performed according to the physician's standard of care.
• Collagen Vascular Disease
• Scleroderma
• Systemic sclerosis
• Active lupus
• Infiltrating lobular histology
• Previous ipsilateral radiation to the thorax or breast

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: single arm, treatment with FDA cleared technology; Patients who have early stage breast cancer, and are candidate for intracavitary accelerated partial breast irradiation may be considered for this study.

Radiation: Electronic Brachytherapy; 34 Gy administered over 10 fractions, twice a day times five days. The radiation therapy treatment will be complete upon the 5th day.; Other Names: Radiation therapy; APBI; Intracavitary APBI; Accelerated partial breast irradiation; Xoft procedure; Partial breast irradiation; Partial breast radiation therapy; Balloon brachytherapy; Electronic source radiation therapy; Radiation: Intracavitary accelerated partial breast irradiation; 3.4 Gy BID x 5 days; Other Names: electronic brachytherapy; Xoft Axxent system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of signs and symptoms of subcutaneous toxicities will be recorded at the following follow-up visits; six month, one year, two year, three year, four year, and five year.	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Local-regional Breast Failure - Ipsilateral breast failure at five years, Including: Ipsilateral recurrence within the initially treated volume, Ipsilateral recurrence of cancer outside of the initially treated volume, and axillary nodal recurrence	5 years

Collaborators and Investigators

• Sponsor: Xoft, Inc.
• Investigators: Principal Investigator: Rakesh Patel, MD, University of Wisconsin Radiation Oncology Department

Publications and helpful links

General Publications

• Dickler A, Kirk MC, Seif N, Griem K, Dowlatshahi K, Francescatti D, Abrams RA. A dosimetric comparison of MammoSite high-dose-rate brachytherapy and Xoft Axxent electronic brachytherapy. Brachytherapy. 2007 Apr-Jun;6(2):164-8. doi: 10.1016/j.brachy.2007.01.005.
• Smitt MC, Kirby R. Dose-volume characteristics of a 50-kV electronic brachytherapy source for intracavitary accelerated partial breast irradiation. Brachytherapy. 2007 Jul-Sep;6(3):207-11. doi: 10.1016/j.brachy.2007.03.002.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: August 25, 2008
• First Submitted That Met QC Criteria: August 26, 2008
• First Posted (Estimate): August 27, 2008

Study Record Updates

• Last Update Posted (Estimate): May 17, 2016
• Last Update Submitted That Met QC Criteria: May 16, 2016
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Electronic brachytherapy registry; Multi-society registry; Breast cancer registry
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Carcinoma in Situ; Breast Neoplasms; Carcinoma; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: TPR-0186