Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System® (NCT01644669)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arizona — Tucson, Arizona
Age range: 40 Years
🧪 Interventions in This Study
- Intra-operative Radiation Therapy - IORT (RADIATION)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (24 Sites)
- University of Arizona — Tucson, Arizona
- City of Hope — Duarte, California
- Long Beach Memorial Medical Center — Long Beach, California
- UCLA — Los Angeles, California
- Tri-City Medical Center — Oceanside, California
- Diablo Valley Oncology Hematology Medical Group — Pleasant Hill, California
- Western Surgical Care, PC — Denver, Colorado
- Swedish Medical Center — Englewood, Colorado
- Florida Hospital Celebration Health — Celebration, Florida
- Doctors Hospital — Coral Gables, Florida
- Martin Health System Center for Clinical Research — Stuart, Florida
- Rush University — Chicago, Illinois
- Lutheran Hospital of Indiana — Fort Wayne, Indiana
- Greater Baltimore Medical Center — Baltimore, Maryland
- MedStar Oncology Network - Good Samaritan Hospital — Baltimore, Maryland
- MedStar Oncology Network - Franklin Square — Baltimore, Maryland
- Exeter Hospital — Exeter, New Hampshire
- Staten Island University Hospital — Staten Island, New York
- University of Oklahoma — Oklahoma City, Oklahoma
- Parkridge Medical Center — Chattanooga, Tennessee
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee
- Sentara Northern Virginia Medical Center — Woodbridge, Virginia
- Monash Health / Peter MacCallum Cancer Centre — Clayton, Victoria
- Hospital CUF Porto — Porto,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Invasive Ductal Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.