N/A N=15 Treatment

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

Endometrial Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01045187 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2011

Primary outcome: Primary: Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System — 15 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: brachytherapy (Radiation); Xoft Axxent Electronic Brachytherapy System (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Xoft, Inc.
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System	15	—
SECONDARY 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	—	—
SECONDARY Assess Occurence Rate of Toxicities	—	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01045187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.