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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01045187
First Posted: January 8, 2010
Last Update Posted: August 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xoft, Inc.
Results First Submitted: January 24, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Endometrial Cancer
Interventions: Radiation: brachytherapy
Radiation: Xoft Axxent Electronic Brachytherapy System

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was from September 2008 through October 2009. The centers were at Hospitals and free-standing radiation oncology clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Endometrial Cancer Patients are treated with electronic brachytherapy for an FDA cleared indication.

Participant Flow:   Overall Study
    Endometrial Cancer
STARTED   15 
COMPLETED   15 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Endometrial Cancer Patients are treated with electronic brachytherapy for an FDA cleared indication.

Baseline Measures
   Endometrial Cancer 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   8 
>=65 years   7 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.2  (7.8) 
Gender 
[Units: Participants]
 
Female   15 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   15 


  Outcome Measures

1.  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 ]

2.  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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Assess Occurence Rate of Toxicities   [ Time Frame: through 3 month follow up post treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kelly W Elliott RN, MS
Organization: Xoft, Inc.
phone: 408-419-2428
e-mail: Kelliott@xoftinc.com


Publications of Results:

Responsible Party: Xoft, Inc.
ClinicalTrials.gov Identifier: NCT01045187     History of Changes
Other Study ID Numbers: TPR-0209
First Submitted: November 19, 2009
First Posted: January 8, 2010
Results First Submitted: January 24, 2011
Results First Posted: February 21, 2011
Last Update Posted: August 1, 2012



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