Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer
Completed · Not applicable
Conditions studied: Cervical Cancer
In brief
The purpose of this study is to evaluate the safety, performance and usability of the Xoft Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the physician's current standard treatment practice and in replacement of high-dose-rate after-loaders using Iridium-192 or low-dose-rate Cesium treatments. Data will be collected on treatment delivery, safety, and acute toxicity. Our hypothesis is that the treatment is safe as incorporated into the physician's current standard of practice.
Key facts
- Study ID
- NCT01851772
- Run by
- Xoft, Inc.
- People needed
- 3
- Starts
- 2013-11-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2021-01-12
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Brachytherapy is indicated after EBRT for all cases of locally advanced disease (Stages Ib2 - IVA)
- Inoperable Stage Ia1 and Stage Ia2 may be treated with tandem-based brachytherapy alone
- Inoperable Stage Ib1 should be treated radically with brachytherapy in conjunction with EBRT. Concurrent chemotherapy may be considered at the physician's discretion and based on the presence of high risk features.
- Subjects can be treated with brachytherapy regardless of lymph node status, grade, and presence of lymphovascular invasion, tumor size, age, or histology.
- Medically fit for general or spinal anesthesia, or conscious sedation, for the insertion process
- Subjects of childbearing potential must have a negative serum pregnancy test at Screening inclusion Criteria:
You may not qualify if…
- Medical Contraindications to Brachytherapy (scleroderma, collagen vascular disease, active lupus )
- Prior pelvic radiotherapy with brachytherapy
- Hemoglobin level at screening < 8
- Life expectancy < 6 months
Where it is running
- Oklahoma University — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.