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

Xoft, Inc.10 sites in 1 country44 target enrollmentMarch 26, 2007

ConditionsBreast Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Xoft, Inc.
Enrollment: 44
Locations: 10
Primary Endpoint: Number of Participants With Delivery of 34 Gy in 10 Fractions
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

March 26, 2007

End Date

May 7, 2016

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Xoft, Inc.

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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)