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

Not Applicable

Completed

• Conditions: Endometrial Cancer
• Interventions: Radiation: brachytherapy; Radiation: Xoft Axxent Electronic Brachytherapy System

• Registration Number: NCT01045187
• Lead Sponsor: Xoft, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-11-19
• Primary Completion: 2010-01
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-08
• Study Completion: 2010-04
• Results First Submitted: 2011-01-24
• Results First Submitted QC: 2011-01-24
• Results First Posted: 2011-02-21
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-24
• Last Update Posted: 2012-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• Most types of endometrial (uterine) cancer Stage I and Stage II (see exclusion criteria below)
• Post hysterectomy

Exclusion Criteria

• Endometrial (uterine) cancer Stage IA Grade 1
• Scleroderma
• Collagen vascular disease
• Active Lupus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
endometrial cancer	brachytherapy	Patients are treated with electronic brachytherapy for an FDA cleared indication.
endometrial cancer	Xoft Axxent Electronic Brachytherapy System	Patients are treated with electronic brachytherapy for an FDA cleared indication.

Primary Outcome Measures

Name	Time	Method
Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System	through completion of radiation therapy

Secondary Outcome Measures

Name	Time	Method
Assess Acute Safety Outcomes in Patients During and After Vaginal Cuff Brachytherapy Treatment With the Axxent Electronic Brachytherapy System as Incorporated in to the Physician's Current Standard of Practice	through 3 month post treatment
Assess Occurence Rate of Toxicities	through 3 month follow up post treatment

Trial Locations

Locations (6)

Beverly Oncology & Imaging Medical Center, Inc; 🇺🇸 Montebello, California, United States

Swedish Covenant Hospital; 🇺🇸 Chicago, Illinois, United States

Southwest Oncology Center; 🇺🇸 Phoenix, Arizona, United States

Cancer Treatment Services Arizona; 🇺🇸 Casa Grande, Arizona, United States

Little Company of Mary Hospital; 🇺🇸 Evergreen Park, Illinois, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States