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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045187
• Other study ID #: TPR-0209
• Status: Completed
• Phase: N/A
• First received: November 19, 2009
• Last updated: July 24, 2012
• Start date: October 2008
• Est. completion date: April 2010

Study information

• Verified date: July 2012
• Source: Xoft, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cancer Treatment Services Arizona	Casa Grande	Arizona
United States	Swedish Covenant Hospital	Chicago	Illinois
United States	Little Company of Mary Hospital	Evergreen Park	Illinois
United States	Beverly Oncology & Imaging Medical Center, Inc	Montebello	California
United States	Southwest Oncology Center	Phoenix	Arizona
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Xoft, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dickler A, Puthawala MY, Thropay JP, Bhatnagar A, Schreiber G. Prospective multi-center trial utilizing electronic brachytherapy for the treatment of endometrial cancer. Radiat Oncol. 2010 Jul 20;5:67. doi: 10.1186/1748-717X-5-67. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System		through completion of radiation therapy	No
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		through 3 month post treatment	Yes
Secondary	Assess Occurence Rate of Toxicities		through 3 month follow up post treatment	Yes