Post Market Study Using the Xoft Axxent System

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017549
• Other study ID #: 1-04
• Status: Completed
• Phase: N/A
• Start date: March 26, 2007
• Est. completion date: May 7, 2016

Study information

• Verified date: August 2020
• Source: Xoft, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 7, 2016
• Est. primary completion date: June 6, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Electronic brachytherapy (Axxent System)
3.4 Gy per fraction for 10 fractions for a total of 34 Gy.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Little Company of Mary Hospital	Evergreen Park	Illinois
United States	Wellstar-Kennestone Cancer Center	Marietta	Georgia
United States	Beth Israel Medical Center	New York	New York
United States	Oklahoma University Health Science Center	Oklahoma City	Oklahoma
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Mills Peninsula Hospital	San Mateo	California
United States	Swedish Cancer Institute	Seattle	Washington
United States	Holy Cross Medical Center	Silver Spring	Maryland
United States	Dickstein Cancer Center- White Plains Hospital	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Xoft, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mehta VK, Algan O, Griem KL, Dickler A, Haile K, Wazer DE, Stevens RE, Chadha M, Kurtzman S, Modin SD, Dowlatshahi K, Elliott KW, Rusch TW. Experience with an electronic brachytherapy technique for intracavitary accelerated partial breast irradiation. Am — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	measured at end of 10th fraction, usually within 7 days
Secondary	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.	Through 6 months