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

July 24, 2012 updated by: Xoft, Inc.

Feasibility Study Using the Xoft Axxent Electronic Brachytherapy System for the Treatment of Endometrial Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Casa Grande, Arizona, United States, 85222
        • Cancer Treatment Services Arizona
      • Phoenix, Arizona, United States, 85251
        • Southwest Oncology Center
    • California
      • Montebello, California, United States, 90640
        • Beverly Oncology & Imaging Medical Center, Inc
    • Illinois
      • Chicago, Illinois, United States, 60625
        • Swedish Covenant Hospital
      • Evergreen Park, Illinois, United States, 60805
        • Little Company of Mary Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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:
  • Radiation
  • Electronic
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System
Time Frame: through completion of radiation therapy
through completion of radiation therapy

Secondary Outcome Measures

Outcome Measure
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
Time Frame: through 3 month post treatment
through 3 month post treatment
Assess Occurence Rate of Toxicities
Time Frame: through 3 month follow up post treatment
through 3 month follow up post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xoft, Inc.

Investigators

  • Principal Investigator: Adam Dickler, MD, Little Company of Mary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

November 19, 2009

First Submitted That Met QC Criteria

January 7, 2010

First Posted (Estimate)

January 8, 2010

Study Record Updates

Last Update Posted (Estimate)

August 1, 2012

Last Update Submitted That Met QC Criteria

July 24, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPR-0209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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