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Feasibility Study Using the Xoft System for the Treatment of Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT01045187
Recruitment Status : Completed
First Posted : January 8, 2010
Results First Posted : February 21, 2011
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Radiation: brachytherapy Radiation: Xoft Axxent Electronic Brachytherapy System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study Using the Xoft Axxent Electronic Brachytherapy System for the Treatment of Endometrial Cancer
Study Start Date : October 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
endometrial cancer
Patients are treated with electronic brachytherapy for an FDA cleared indication.
Radiation: brachytherapy
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.
Other Names:
  • Electronic
  • Radiation
  • Vaginal cuff

Radiation: Xoft Axxent Electronic Brachytherapy System
21-22 Gy in 3-4 fractions to 5mm or 16-18 Gy in 3 fractions prescribed to the surface.
Other Names:
  • Radiation
  • therapy
  • electronic




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Assess Occurence Rate of Toxicities [ Time Frame: through 3 month follow up post treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045187


Locations
United States, Arizona
Cancer Treatment Services Arizona
Casa Grande, Arizona, United States, 85222
Southwest Oncology Center
Phoenix, Arizona, United States, 85251
United States, California
Beverly Oncology & Imaging Medical Center, Inc
Montebello, California, United States, 90640
United States, Illinois
Swedish Covenant Hospital
Chicago, Illinois, United States, 60625
Little Company of Mary Hospital
Evergreen Park, Illinois, United States, 60805
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Xoft, Inc.
Investigators
Principal Investigator: Adam Dickler, MD Little Company of Mary

Publications of Results:
Responsible Party: Xoft, Inc.
ClinicalTrials.gov Identifier: NCT01045187     History of Changes
Other Study ID Numbers: TPR-0209
First Posted: January 8, 2010    Key Record Dates
Results First Posted: February 21, 2011
Last Update Posted: August 1, 2012
Last Verified: July 2012

Keywords provided by Xoft, Inc.:
endometrial cancer
Uterine cancer
electronic brachytherapy
Xoft

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female