Post Market Study Using the Xoft Axxent System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01017549
Recruitment Status : Completed
First Posted : November 20, 2009
Results First Posted : April 11, 2011
Last Update Posted : June 17, 2016
Information provided by (Responsible Party):
Xoft, Inc.

Brief Summary:
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Electronic brachytherapy (Axxent System) Phase 4

Detailed Description:
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System for the delivery of radiation therapy as part of breast conserving therapy in women with resected, early stage breast cancer.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post Market Clinical Study to Evaluate the Safety and Performance of the Axxent® Electronic Brachytherapy System in Women With Resected, Early Stage Breast Cancer
Study Start Date : March 2007
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
This is a single arm study where all patients are treated with FDA cleared electronic brachytherapy treatment.
Radiation: Electronic brachytherapy (Axxent System)
3.4 Gy per fraction for 10 fractions for a total of 34 Gy.
Other Name: Radiation therapy, Axxent, Xoft, eBx, EBT, brachytherapy

Primary Outcome Measures :
  1. Number of Participants With Delivery of 34 Gy in 10 Fractions [ Time Frame: measured at end of 10th fraction, usually within 7 days ]
    Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue)

Secondary Outcome Measures :
  1. Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up. [ Time Frame: Through 6 months ]
    Serious adverse device related events reported from treatment through 6 month follow-up and at 1-year follow-up are reported.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >50 years
  • Tumor with Tis, T1, N0, M0 - (AJC Classification)
  • Invasive ductal carcinoma or ductal carcinoma in situ
  • Negative microscopic surgical margins of at least 1mm in all directions
  • Adequate skin spacing between balloon surface and surface of the skin - (> 7mm)

Exclusion Criteria:

  • Pregnancy or breast-feeding - (During the treatment portion of the study, sexually active women of childbearing age will be asked to use pregnancy prevention)
  • Scleroderma, systemic sclerosis and active lupus
  • Infiltrating lobular histology

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01017549

United States, California
Mills Peninsula Hospital
San Mateo, California, United States, 94401
United States, Georgia
Wellstar-Kennestone Cancer Center
Marietta, Georgia, United States, 30060
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Little Company of Mary Hospital
Evergreen Park, Illinois, United States, 60805
United States, Maryland
Holy Cross Medical Center
Silver Spring, Maryland, United States, 20910
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Dickstein Cancer Center- White Plains Hospital
White Plains, New York, United States, 10601
United States, Oklahoma
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, United States, 73104
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Xoft, Inc.
Principal Investigator: Vivek K Mehta, MD Swedish Cancer Institute

Publications of Results:
Responsible Party: Xoft, Inc. Identifier: NCT01017549     History of Changes
Other Study ID Numbers: 1-04
First Posted: November 20, 2009    Key Record Dates
Results First Posted: April 11, 2011
Last Update Posted: June 17, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Xoft, Inc.:
Stage I
Stage II

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases