Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 19, 2009
July 24, 2012
October 2008
January 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01045187 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Feasibility Study Using the Xoft System for the Treatment of Endometrial Cancer
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Endometrial Cancer
  • 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
endometrial cancer
Patients are treated with electronic brachytherapy for an FDA cleared indication.
Interventions:
  • Radiation: brachytherapy
  • Radiation: Xoft Axxent Electronic Brachytherapy System
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
April 2010
January 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01045187
TPR-0209
No
Xoft, Inc.
Xoft, Inc.
Not Provided
Principal Investigator: Adam Dickler, MD Little Company of Mary
Xoft, Inc.
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP