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A Registry of Intra-Operative Radiation Therapy (IORT) Using the Xoft ® Axxent ® eBx ™ System Patients

Early Stage Breast Cancer Clinical Trial

Official title:
A Registry of Intra-Operative Radiation Therapy (IORT) Using the Xoft ® Axxent ® eBx™ System Patients

Clinical Trial Summary

Single arm, prospective, multi-center, non-randomized study of subjects treated with single fraction, intra-operative radiation therapy at the time of lumpectomy for early stage breast cancer.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 whole breast irradiation (WBI) at 5 years of follow-up. The results of this single arm study will be compared to whole breast irradiation (WBI).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03561454
Study type Observational
Source MedStar Franklin Square Medical Center
Contact
Status Active, not recruiting
Phase
Start date January 11, 2019
Completion date August 1, 2029
View Details
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