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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Electronic brachytherapy dose 21 Gy or 22 Gy in 3-4 fractions prescribed to 5mm depth, or electronic brachytherapy 16-18 Gy if EBRT is administered.
21-22 Gy in 3-4 fractions to 5mm or 16-18 Gy in 3 fractions prescribed to the surface.
Cancer Treatment Services Arizona
Casa Grande, Arizona, United States
Southwest Oncology Center
Phoenix, Arizona, United States
Beverly Oncology & Imaging Medical Center, Inc
Montebello, California, United States
Swedish Covenant Hospital
Chicago, Illinois, United States
Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System
Time frame: through completion of radiation therapy
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
Time frame: through 3 month post treatment
Assess Occurence Rate of Toxicities
Time frame: through 3 month follow up post treatment
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Little Company of Mary Hospital
Evergreen Park, Illinois, United States
Rhode Island Hospital
Providence, Rhode Island, United States