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Completed

NCT Number: NCT01017549

Post Market Study Using the Xoft Axxent System

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mills Peninsula Hospital, San Mateo, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic brachytherapy (Axxent System)

Radiation

3.4 Gy per fraction for 10 fractions for a total of 34 Gy.

Other names: Radiation therapy, Axxent, Xoft, eBx, EBT, brachytherapy

Primary outcomes

  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 outcomes

  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 5-year follow-up are reported.

Sponsors and collaborators

Lead sponsor

Xoft, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2013
Study completion
2016
First posted
Nov 20, 2009
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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