Post Market Study Using the Xoft Axxent System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Xoft, Inc.
ClinicalTrials.gov Identifier:
NCT01017549
First received: November 18, 2009
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Breast Cancer
Radiation: Electronic brachytherapy (Axxent System)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Xoft, Inc.:

Primary Outcome Measures:
  • Number of Participants With Delivery of 34 Gy in 10 Fractions [ Time Frame: measured at end of 10th fraction, usually within 7 days ] [ Designated as safety issue: No ]
    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:
  • Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up. [ Time Frame: Through 6 months ] [ Designated as safety issue: No ]
    Serious adverse device related events reported from treatment through 6 month follow-up and at 1-year follow-up are reported.


Enrollment: 44
Study Start Date: March 2007
Estimated Study Completion Date: August 2015
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment
This is a single arm study where all patients are treated with FDA cleared technology and an FDA cleared indication.
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

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.

  Eligibility

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

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
  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: NCT01017549

Locations
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.
Investigators
Principal Investigator: Vivek K Mehta, MD Swedish Cancer Institute
  More Information

Publications:
Responsible Party: Xoft, Inc.
ClinicalTrials.gov Identifier: NCT01017549     History of Changes
Other Study ID Numbers: 1-04
Study First Received: November 18, 2009
Results First Received: September 7, 2010
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 22, 2014