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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endometrial cancer | Other | Patients are treated with electronic brachytherapy for an FDA cleared indication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brachytherapy | Radiation | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System | through completion of radiation therapy |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Dickler, MD | Little Company of Mary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Treatment Services Arizona | Casa Grande | Arizona | 85222 | United States | ||
| Southwest Oncology Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20646289 | Result | 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. |
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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.
Recruitment was from September 2008 through October 2009. The centers were at Hospitals and free-standing radiation oncology clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Endometrial Cancer | Patients are treated with electronic brachytherapy for an FDA cleared indication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Endometrial Cancer | Patients are treated with electronic brachytherapy for an FDA cleared indication. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System | Posted | Jan 2011 | Number | Participants | through completion of radiation therapy |
|
|
Procedure through 3 month follow-up to report acute toxicities.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Endometrial Cancer | Patients are treated with electronic brachytherapy for an FDA cleared indication. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysuria | Renal and urinary disorders | CTCAE v3.0 | Non-systematic Assessment | Dysuria Grade 1 at 1 month ongoing at 3 months. Dysuria grade 2 at 1 month resolved at 3 months. |
Small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly W Elliott RN, MS | Xoft, Inc. | 408-419-2428 | Kelliott@xoftinc.com |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| D011827 | Radiation |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D055585 | Physical Phenomena |
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|
| Xoft Axxent Electronic Brachytherapy System | Radiation | 21-22 Gy in 3-4 fractions to 5mm or 16-18 Gy in 3 fractions prescribed to the surface. |
|
|
| through 3 month follow up post treatment |
| Phoenix |
| Arizona |
| 85251 |
| United States |
| Beverly Oncology & Imaging Medical Center, Inc | Montebello | California | 90640 | United States |
| Swedish Covenant Hospital | Chicago | Illinois | 60625 | United States |
| Little Company of Mary Hospital | Evergreen Park | Illinois | 60805 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 | Not Posted | through 3 month post treatment |
| Secondary | Assess Occurence Rate of Toxicities | Not Posted | through 3 month follow up post treatment |
| 0 |
| 15 |
| 6 |
| 15 |
|
| Pain | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment | Occurrence rate= 1 patient at 1 visit: Vaginal pain grade 2 t 1 month resolved at 6 weeks. |
|
| Mucosal Atrophy | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment | Reported x 1: Mucosal atrophy grade 1 reported at 3 month visit and noted to be resolved at 3 month visit. |
|
| Rectal bleeding | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | Grade one reported at 3 month visit and noted to be resolved at that time. |
|
| Vaginal drying | Reproductive system and breast disorders | CTCAE v3.0 | Non-systematic Assessment | Vaginal Drying grade one reported x 1 at 3 months and oted to be resolved at 3 months. |
|
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| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |