Post Market Study Using the Xoft Axxent System

August 12, 2020 updated by: Xoft, Inc.

Post Market Clinical Study to Evaluate the Safety and Performance of the Axxent® Electronic Brachytherapy System in Women With Resected, Early Stage Breast Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • Radiation therapy, Axxent, Xoft, eBx, EBT, brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
measured at end of 10th fraction, usually within 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 5-year follow-up are reported.
Through 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xoft, Inc.

Investigators

  • Principal Investigator: Vivek K Mehta, MD, Swedish Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2007

Primary Completion (Actual)

June 6, 2013

Study Completion (Actual)

May 7, 2016

Study Registration Dates

First Submitted

November 18, 2009

First Submitted That Met QC Criteria

November 19, 2009

First Posted (Estimate)

November 20, 2009

Study Record Updates

Last Update Posted (Actual)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 12, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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