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Completed

NCT Number: NCT01045187

Feasibility Study Using the Xoft 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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Treatment Services Arizona, Casa Grande, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brachytherapy

Radiation

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

Xoft Axxent Electronic Brachytherapy System

Radiation

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

Primary outcomes

  1. 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

  1. 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

  2. Assess Occurence Rate of Toxicities

    Time frame: through 3 month follow up post treatment

Sponsors and collaborators

Lead sponsor

Xoft, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 8, 2010
Registry last updated
Aug 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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