Feasibility Study Using the Xoft System for the Treatment of Endometrial Cancer
Not Applicable
Completed
- Conditions
- Endometrial Cancer
- Registration Number
- NCT01045187
- Lead Sponsor
- Xoft, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System through completion of radiation therapy
- Secondary Outcome Measures
Name Time Method 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 through 3 month post treatment Assess Occurence Rate of Toxicities through 3 month follow up post treatment
Trial Locations
- Locations (6)
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
Little Company of Mary Hospital
🇺🇸Evergreen Park, Illinois, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Cancer Treatment Services Arizona🇺🇸Casa Grande, Arizona, United States