Back to resultsFeasibility Study Using the Xoft System for the Treatment of Endometrial Cancer
Primary Purpose
Endometrial Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
brachytherapy
Xoft Axxent Electronic Brachytherapy System
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer focused on measuring endometrial cancer, Uterine cancer, electronic brachytherapy, Xoft
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
Sites / Locations
- Cancer Treatment Services Arizona
- Southwest Oncology Center
- Beverly Oncology & Imaging Medical Center, Inc
- Swedish Covenant Hospital
- Little Company of Mary Hospital
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
endometrial cancer
Arm Description
Patients are treated with electronic brachytherapy for an FDA cleared indication.
Outcomes
Primary Outcome Measures
Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System
Secondary Outcome Measures
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
Assess Occurence Rate of Toxicities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01045187
Brief Title
Feasibility Study Using the Xoft System for the Treatment of Endometrial Cancer
Official Title
Feasibility Study Using the Xoft Axxent Electronic Brachytherapy System for the Treatment of Endometrial Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xoft, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
endometrial cancer, Uterine cancer, electronic brachytherapy, Xoft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
endometrial cancer
Arm Type
Other
Arm Description
Patients are treated with electronic brachytherapy for an FDA cleared indication.
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Other Intervention Name(s)
Electronic, Radiation, Vaginal cuff
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Xoft Axxent Electronic Brachytherapy System
Other Intervention Name(s)
Radiation, therapy, electronic
Intervention Description
21-22 Gy in 3-4 fractions to 5mm or 16-18 Gy in 3 fractions prescribed to the surface.
Primary Outcome Measure Information:
Title
Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System
Time Frame
through completion of radiation therapy
Secondary Outcome Measure Information:
Title
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
Title
Assess Occurence Rate of Toxicities
Time Frame
through 3 month follow up post treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Dickler, MD
Organizational Affiliation
Little Company of Mary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Treatment Services Arizona
City
Casa Grande
State/Province
Arizona
ZIP/Postal Code
85222
Country
United States
Facility Name
Southwest Oncology Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Beverly Oncology & Imaging Medical Center, Inc
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
Swedish Covenant Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States
Facility Name
Little Company of Mary Hospital
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20646289
Citation
Dickler A, Puthawala MY, Thropay JP, Bhatnagar A, Schreiber G. Prospective multi-center trial utilizing electronic brachytherapy for the treatment of endometrial cancer. Radiat Oncol. 2010 Jul 20;5:67. doi: 10.1186/1748-717X-5-67.
Results Reference
result
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Feasibility Study Using the Xoft System for the Treatment of Endometrial Cancer
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