Status:
COMPLETED
Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer
Lead Sponsor:
Xoft, Inc.
Collaborating Sponsors:
Icad, Inc.
Conditions:
Cervical Cancer
Eligibility:
FEMALE
Phase:
NA
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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:
- EXCLUSION CRITERIA:
- Medical Contraindications to Brachytherapy (scleroderma, collagen vascular disease, active lupus )
- Prior pelvic radiotherapy with brachytherapy
- Hemoglobin level at screening \< 8
- Life expectancy \< 6 months
Exclusion
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01851772
Start Date
November 1 2013
End Date
June 1 2015
Last Update
January 12 2021
Active Locations (1)
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1
Oklahoma University
Oklahoma City, Oklahoma, United States, 73104