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Clinical Trial VICCBRE1298


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

Principal Investigator(s)

Bapsi Chak


  • Protocol No. VICCBRE1298
  • Open Date: 04/19/2013
  • Staging: N/A
  • Age Group: Adults
  • Scope: National
  • Objective: To assess the rate of ipsilateral breast tumor recurrence in subjects treated with the Xoft Axxent Electronic Brachytherapy System when used for single-fraction, intra-operative radiation therapy treatment of early stage breast cancer when compared to a historical control of whole breast irradiation (WBI) at 5 and 10 years of follow-up.
  • Disease Sites: Breast
  • Therapies: Radiotherapy
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01644669
  • Secondary Protocol No: CTPR-0009


The purpose of this study is to compare the effects, good and/or bad, of giving a new form of radiation therapy, called Intra-Operative Radiation Therapy (IORT), after breast conservation surgery (Lumpectomy) for early-stage breast cancer.


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