Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®
Public ClinicalTrials.gov record NCT01644669. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Safety and Efficacy Study of Intra-Operative Radiation Therapy (IORT) Using the Xoft® Axxent® eBx® System® at the Time of Breast Conservation Surgery for Early Stage Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this trial is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer. Hypothesis: IORT using the Xoft Axxent eBx System is no worse (non-inferior) than whole breast irradiation (WBI) when used as stand-alone radiation treatment in breast conserving therapy in women with early stage breast cancer.
Study identification
- NCT ID
- NCT01644669
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,200 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 8, 2012 (Actual)
- Primary completion
- Jul 12, 2023 (Actual)
- Completion
- Dec 31, 2029 (Estimated)
- Last update posted
- Jan 31, 2025
2012 – 2029
United States locations
- U.S. sites
- 22
- U.S. states
- 12
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85704 | — |
| City of Hope | Duarte | California | 91010 | — |
| Long Beach Memorial Medical Center | Long Beach | California | 90806 | — |
| UCLA | Los Angeles | California | 90095 | — |
| Tri-City Medical Center | Oceanside | California | 92056 | — |
| Diablo Valley Oncology Hematology Medical Group | Pleasant Hill | California | 94523 | — |
| Western Surgical Care, PC | Denver | Colorado | 80220 | — |
| Swedish Medical Center | Englewood | Colorado | 80113 | — |
| Florida Hospital Celebration Health | Celebration | Florida | 34747 | — |
| Doctors Hospital | Coral Gables | Florida | 33146 | — |
| Martin Health System Center for Clinical Research | Stuart | Florida | 34994 | — |
| Rush University | Chicago | Illinois | 60612 | — |
| Lutheran Hospital of Indiana | Fort Wayne | Indiana | 46804 | — |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | — |
| MedStar Oncology Network - Good Samaritan Hospital | Baltimore | Maryland | 21218 | — |
| MedStar Oncology Network - Franklin Square | Baltimore | Maryland | 21237 | — |
| Exeter Hospital | Exeter | New Hampshire | 03833 | — |
| Staten Island University Hospital | Staten Island | New York | 10305 | — |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | — |
| Parkridge Medical Center | Chattanooga | Tennessee | 37404 | — |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37212 | — |
| Sentara Northern Virginia Medical Center | Woodbridge | Virginia | 22191 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01644669, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 31, 2025 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01644669 live on ClinicalTrials.gov.