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

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ClinicalTrials.gov Identifier: NCT00742222
Recruitment Status : Completed
First Posted : August 27, 2008
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Xoft, Inc.

Tracking Information
First Submitted Date  ICMJE August 25, 2008
First Posted Date  ICMJE August 27, 2008
Last Update Posted Date May 17, 2016
Study Start Date  ICMJE May 2008
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00742222 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer
Official Title  ICMJE Electronic Xoft Intersociety Brachytherapy Trial
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Carcinoma
  • Lumpectomy
  • Ductal Carcinoma in Situ
Intervention  ICMJE
  • 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:
    • Xoft Axxent system
    • electronic brachytherapy
Study Arms  ICMJE 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2010)
63
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2008)
400
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00742222
Other Study ID Numbers  ICMJE TPR-0186
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xoft, Inc.
Study Sponsor  ICMJE Xoft, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Beitsch, MD Dallas Surgical Group
Principal Investigator: Rakesh Patel, MD University of Wisconsin Radiation Oncology Department
PRS Account Xoft, Inc.
Verification Date July 2015

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