Post Market Study Using the Xoft Axxent System
This study is ongoing, but not recruiting participants.
Sponsor:
Xoft, Inc.
Information provided by (Responsible Party):
Xoft, Inc.
ClinicalTrials.gov Identifier:
NCT01017549
First received: November 18, 2009
Last updated: June 28, 2012
Last verified: June 2012
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Purpose
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Radiation: Electronic brachytherapy (Axxent System) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Xoft, Inc.:
Primary Outcome Measures:
- Number of Participants With Delivery of 34 Gy in 10 Fractions [ Time Frame: measured at end of 10th fraction, usually within 7 days ] [ Designated as safety issue: No ]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 Outcome Measures:
- Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up. [ Time Frame: Through 6 months ] [ Designated as safety issue: No ]Serious adverse device related events reported from treatment through 6 month follow-up and at 1-year follow-up are reported.
| Enrollment: | 44 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Treatment
This is a single arm study where all patients are treated with FDA cleared technology and an FDA cleared indication.
|
Radiation: Electronic brachytherapy (Axxent System)
3.4 Gy per fraction for 10 fractions for a total of 34 Gy.
Other Name: Radiation therapy, Axxent, Xoft, eBx, EBT, brachytherapy
|
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| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017549
Locations
| United States, California | |
| Mills Peninsula Hospital | |
| San Mateo, California, United States, 94401 | |
| United States, Georgia | |
| Wellstar-Kennestone Cancer Center | |
| Marietta, Georgia, United States, 30060 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Little Company of Mary Hospital | |
| Evergreen Park, Illinois, United States, 60805 | |
| United States, Maryland | |
| Holy Cross Medical Center | |
| Silver Spring, Maryland, United States, 20910 | |
| United States, New York | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10003 | |
| Dickstein Cancer Center- White Plains Hospital | |
| White Plains, New York, United States, 10601 | |
| United States, Oklahoma | |
| Oklahoma University Health Science Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Washington | |
| Swedish Cancer Institute | |
| Seattle, Washington, United States, 98104 | |
Sponsors and Collaborators
Xoft, Inc.
Investigators
| Principal Investigator: | Vivek K Mehta, MD | Swedish Cancer Institute |
More Information
Publications:
| Responsible Party: | Xoft, Inc. |
| ClinicalTrials.gov Identifier: | NCT01017549 History of Changes |
| Other Study ID Numbers: | 1-04 |
| Study First Received: | November 18, 2009 |
| Results First Received: | September 7, 2010 |
| Last Updated: | June 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Xoft, Inc.:
|
Stage I Stage II Breast Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013