Endometrial Cancer
Conditions
Keywords
endometrial cancer, Uterine cancer, electronic brachytherapy, Xoft
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.
Interventions
RADIATIONbrachytherapy
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.
RADIATIONXoft Axxent Electronic Brachytherapy System
21-22 Gy in 3-4 fractions to 5mm or 16-18 Gy in 3 fractions prescribed to the surface.
Sponsors
Xoft, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Most types of endometrial (uterine) cancer Stage I and Stage II (see
Exclusion criteria
below) * Post hysterectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System | through completion of radiation therapy |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Recruitment was from September 2008 through October 2009. The centers were at Hospitals and free-standing radiation oncology clinics.
Pre-assignment details
Patients who were candidates for vaginal brachytherapy post TAH-BSO with or without EBRT were enrolled. Patient participation was voluntary for this data collection study.
Participants by arm
| Arm | Count |
|---|---|
| Endometrial Cancer Patients are treated with electronic brachytherapy for an FDA cleared indication. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Endometrial Cancer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age Continuous | 63.2 years STANDARD_DEVIATION 7.8 |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System
Time frame: through completion of radiation therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endometrial Cancer | Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System | 15 Participants |
Secondary
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
Secondary
Assess Occurence Rate of Toxicities
Time frame: through 3 month follow up post treatment