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

August 25, 2008
January 16, 2014
May 2008
January 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00742222 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Carcinoma
  • Lumpectomy
  • Ductal Carcinoma in Situ
  • 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
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.
Interventions:
  • Radiation: Electronic Brachytherapy
  • Radiation: Intracavitary accelerated partial breast irradiation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
63
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Female
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00742222
TPR-0186
Yes
Xoft, Inc.
Xoft, Inc.
Not Provided
Principal Investigator: Peter Beitsch, MD Dallas Surgical Group
Principal Investigator: Rakesh Patel, MD University of Wisconsin Radiation Oncology Department
Xoft, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP