NCT03561454

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: MedStar Franklin Square Medical Center · Academic / Other
• Sex: Female
• Age: 40 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Early Stage Breast Cancer

Interventions

Type	Name	Description
DEVICE	IORT	Intra-Operative Radiation Therapy

Timeline

• Start date: 2019-01-11
• Primary completion: 2028-08-01
• Completion: 2029-08-01
• First posted: 2018-06-19
• Last updated: 2023-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study