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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Xoft, Inc.
ClinicalTrials.gov Identifier:
NCT00742222
First received: August 25, 2008
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Carcinoma
Lumpectomy
Ductal Carcinoma in Situ
Radiation: Electronic Brachytherapy
Radiation: Intracavitary accelerated partial breast irradiation
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Electronic Xoft Intersociety Brachytherapy Trial

Resource links provided by NLM:


Further study details as provided by Xoft, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: May 2008
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • Electronic Brachytherapy
  • 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:
  • Xoft Axxent system
  • electronic brachytherapy

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742222

Locations
United States, Alabama
DCH Cancer Treatment Center
Tuscaloosa, Alabama, United States, 35401
United States, California
Beverly Oncology
Montebello, California, United States, 90640
United States, Florida
Florida Radiation Oncology Group
Orange Park, Florida, United States, 32073
United States, Illinois
St Elizabeth's and Memorial Cancer Center
Swansea, Illinois, United States, 62226
United States, Missouri
Cancer Institute of Cape Girardeau
Cape Girardeau, Missouri, United States, 63703
United States, New Jersey
AtlantiCare Cancer Care Institute
Galloway, New Jersey, United States, 08205
Nazha Cancer Center
Northfield, New Jersey, United States, 08225
United States, Texas
Dallas Surgical Group / Northpoint Cancer Center
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Xoft, Inc.
Investigators
Principal Investigator: Peter Beitsch, MD Dallas Surgical Group
Principal Investigator: Rakesh Patel, MD University of Wisconsin Radiation Oncology Department
  More Information

Publications:
Responsible Party: Xoft, Inc.
ClinicalTrials.gov Identifier: NCT00742222     History of Changes
Other Study ID Numbers: TPR-0186
Study First Received: August 25, 2008
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Xoft, Inc.:
Electronic brachytherapy registry
Multi-society registry
Breast cancer registry

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Adenocarcinoma
Breast Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2014