Clinical trial NCT01017549: Post Market Study Using the Xoft Axxent System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Stage I
Stage II
Breast
Cancer
Lead sponsor: Xoft, Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-20
Enrollment: 44
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Delivery of 34 Gy in 10 Fractions
timeFrame: measured at end of 10th fraction, usually within 7 days
Secondary outcomes:
measure: Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up.
timeFrame: Through 6 months
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Mills Peninsula Hospital
state: California
city: Marietta
country: United States
facility: Wellstar-Kennestone Cancer Center
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evergreen Park
country: United States
facility: Little Company of Mary Hospital
state: Illinois
city: Silver Spring
country: United States
facility: Holy Cross Medical Center
state: Maryland
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: White Plains
country: United States
facility: Dickstein Cancer Center- White Plains Hospital
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma University Health Science Center
state: Oklahoma
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
Study officials:
affiliation: Swedish Cancer Institute
name: Vivek K Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 J Clin Oncol. 2010 Aug;33(4):327-35. doi: 10.1097/COC.0b013e3181d79d9e.