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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xoft, Inc.
ClinicalTrials.gov Identifier:
NCT01045187
First received: November 19, 2009
Last updated: July 24, 2012
Last verified: July 2012
Results First Received: January 24, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Endometrial Cancer
Interventions: Radiation: brachytherapy
Radiation: Xoft Axxent Electronic Brachytherapy System

  Participant Flow
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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  
Number of Participants  
[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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Assess Occurence Rate of Toxicities   [ Time Frame: through 3 month follow up post treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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.  


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:
Adam Dickler, Mohamed Y Puthawala, John P Thropay, Ajay Bhatnagar,and Gary Schreiber. Prospective multi-center trial utilizing electronic brachytherapy for the treatment of endometrial cancer. Radiation Oncology 2010; 5:67. (doi:10.1186/1748-717X-5-67)


Responsible Party: Xoft, Inc.
ClinicalTrials.gov Identifier: NCT01045187     History of Changes
Other Study ID Numbers: TPR-0209
Study First Received: November 19, 2009
Results First Received: January 24, 2011
Last Updated: July 24, 2012
Health Authority: United States: Institutional Review Board