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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
  Purpose

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 Intervention
Endometrial Cancer
 Radiation: brachytherapy
Radiation: Xoft Axxent Electronic Brachytherapy System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study Using the Xoft Axxent Electronic Brachytherapy System for the Treatment of Endometrial Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xoft, Inc.:

Primary Outcome Measures:
  • Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System [ Time Frame: through completion of radiation therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Assess Occurence Rate of Toxicities [ Time Frame: through 3 month follow up post treatment ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: October 2008
Study Completion Date: April 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
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

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

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Adenoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 23, 2013