N/A
Completed N=15
Feasibility Study Using the Xoft System for the Treatment of Endometrial Cancer
Source: ClinicalTrials.gov NCT01045187 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcomePrimary: Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System — 15 Participants
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.
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 |
— | — |
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
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. Informational only — not medical advice.