NCT01045187

Feasibility Study Using the Xoft System for the Treatment of Endometrial Cancer

Feasibility Study Using the Xoft Axxent Electronic Brachytherapy System for the Treatment of Endometrial Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Xoft, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, non-randomized, feasibility study to evaluate the treatment and assess acute safety of the FDA Cleared Axxent Electronic Brachytherapy System and vaginal applicator for intracavitary vaginal cuff treatment according to the physician's current standard of care.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
RADIATION	brachytherapy	Electronic brachytherapy dose 21 Gy or 22 Gy in 3-4 fractions prescribed to 5mm depth, or electronic brachytherapy 16-18 Gy if EBRT is administered.
RADIATION	Xoft Axxent Electronic Brachytherapy System	21-22 Gy in 3-4 fractions to 5mm or 16-18 Gy in 3 fractions prescribed to the surface.

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-01-01
• Completion: 2010-04-01
• First posted: 2010-01-08
• Last updated: 2012-08-01
• Results posted: 2011-02-21

Locations

6 sites across 1 country: United States