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

Xoft

Status: Completed

Conditions: Endometrial Cancer

Treatments: Radiation: brachytherapy; Radiation: Xoft Axxent Electronic Brachytherapy System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01045187

TPR-0209

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

endometrial cancer

Other group

Description:

Patients are treated with electronic brachytherapy for an FDA cleared indication.

Treatment:

Radiation: Xoft Axxent Electronic Brachytherapy System

Radiation: brachytherapy