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

History of Changes

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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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 ]

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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

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Other Adverse Events

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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

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