Post Market Study Using the Xoft Axxent System

Xoft, Inc.44 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Electronic brachytherapy (Axxent System)RADIATION

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

Eligibility

Sex: FEMALEMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (10)

Mills Peninsula Hospital

San Mateo, California, United States

Wellstar-Kennestone Cancer Center

Marietta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Number of Participants With Delivery of 34 Gy in 10 Fractions

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)

Time frame: measured at end of 10th fraction, usually within 7 days

Secondary Outcomes

Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up.

Serious adverse device related events reported from treatment through 6 month follow-up and at 5-year follow-up are reported.

Time frame: Through 6 months

Data from ClinicalTrials.gov

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