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Completed

NCT Number: NCT01851772

Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer

The purpose of this study is to evaluate the safety, performance and usability of the Xoft Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the physician's current standard treatment practice and in replacement of high-dose-rate after-loaders using Iridium-192 or low-dose-rate Cesium treatments. Data will be collected on treatment delivery, safety, and acute toxicity.

Our hypothesis is that the treatment is safe as incorporated into the physician's current standard of practice.

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Key information

Conditions

Cervical Cancer 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 Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oklahoma University

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Brachytherapy is indicated after EBRT for all cases of locally advanced disease (Stages Ib2 - IVA)
  • Inoperable Stage Ia1 and Stage Ia2 may be treated with tandem-based brachytherapy alone
  • Inoperable Stage Ib1 should be treated radically with brachytherapy in conjunction with EBRT. Concurrent chemotherapy may be considered at the physician's discretion and based on the presence of high risk features.
  • Subjects can be treated with brachytherapy regardless of lymph node status, grade, and presence of lymphovascular invasion, tumor size, age, or histology.
  • Medically fit for general or spinal anesthesia, or conscious sedation, for the insertion process
  • Subjects of childbearing potential must have a negative serum pregnancy test at Screening inclusion Criteria:

Exclusion criteria

  • Medical Contraindications to Brachytherapy (scleroderma, collagen vascular disease, active lupus )
  • Prior pelvic radiotherapy with brachytherapy
  • Hemoglobin level at screening < 8
  • Life expectancy < 6 months

Treatment and study plan

Treatment with Electronic Brachytherapy

Device

Other names: Xoft®, Axxent®, Electronic, Brachytherapy, System

Primary outcomes

  1. Safety - Adverse Event Rate and Severity

    Time frame: Study Exit (90 days)

    Adverse event rate and severity during and following the administration of brachytherapy treatment, through discharge from the treatment facility, and for 3 months after treatment.

Secondary outcomes

  1. Device Performance

    Time frame: Study Exit (90 days)

    Number of subjects who received complete delivery of the brachytherapy treatment using the Xoft Electronic Brachytherapy System with the cervical applicator.

Other outcomes

  1. Frequency of Adverse Events in Participants (i.e.Safety)

    Time frame: 3 months post-Study Exit

    To assess occurrence rate of radiation toxicities through three (3) months of follow-up.

Sponsors and collaborators

Lead sponsor

Xoft, Inc.

Industry

Collaborators

  • Icad, Inc.

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 10, 2013
Registry last updated
Jan 12, 2021

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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