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Clinical Trials/NCT01045187
NCT01045187CompletedNot Applicable

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

Xoft, Inc.6 sites in 1 country15 target enrollmentStarted: October 1, 2008Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Xoft, Inc.
Enrollment
15
Locations
6
Primary Endpoint
Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Most types of endometrial (uterine) cancer Stage I and Stage II (see

Exclusion Criteria

  • •Post hysterectomy
  • •Exclusion Criteria:
  • •Endometrial (uterine) cancer Stage IA Grade 1
  • •Scleroderma
  • •Collagen vascular disease
  • •Active Lupus

Arms & Interventions

endometrial cancer

Other

Patients are treated with electronic brachytherapy for an FDA cleared indication.

Intervention: brachytherapy (Radiation)

endometrial cancer

Other

Patients are treated with electronic brachytherapy for an FDA cleared indication.

Intervention: Xoft Axxent Electronic Brachytherapy System (Radiation)

Outcomes

Primary Outcomes

Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System

Time Frame: through completion of radiation therapy

Secondary Outcomes

  • 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)
  • Assess Occurence Rate of Toxicities(through 3 month follow up post treatment)

Investigators

Sponsor
Xoft, Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (6)

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