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Trial record 1 of 1 for:    Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer
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Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer

This study has been completed.
Sponsor:
Collaborator:
Icad, Inc.
Information provided by (Responsible Party):
Xoft, Inc.
ClinicalTrials.gov Identifier:
NCT01851772
First received: May 7, 2013
Last updated: May 16, 2016
Last verified: November 2015
  Purpose

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.


Condition Intervention
Cervical Cancer Device: Treatment with Electronic Brachytherapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Xoft, Inc.:

Primary Outcome Measures:
  • Safety [ 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 Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 3
Study Start Date: November 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment

Subjects enrolled will undergo brachytherapy treatment in combination with EBRT. The maximum length of treatment will be 56 days. The treating physician will determine the appropriate course of treatment based on the physician's current practice or experience using Iridium-192 or Cesium HDR after-loaders to administer cervical brachytherapy treatments.

Subjects enrolled will be treated with approximately 80-90 Gy total treatment dose over 4-6 fractions. Examples of commonly used dose regimens in the US are listed in section 7.6.7. This study will include data collection from the initiation of EBRT through administration of the final Xoft Axxent treatment fraction, and at one (1) month and three (3) months.

Device: Treatment with Electronic Brachytherapy
Other Names:
  • Xoft®
  • Axxent®
  • Electronic
  • Brachytherapy
  • System

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01851772

Locations
United States, Oklahoma
Oklahoma University
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Xoft, Inc.
Icad, Inc.
Investigators
Principal Investigator: Lowndes Harrison, MD Gadsden Regional Cancer Center
  More Information

Responsible Party: Xoft, Inc.
ClinicalTrials.gov Identifier: NCT01851772     History of Changes
Other Study ID Numbers: CTRP-0010
Study First Received: May 7, 2013
Results First Received: November 9, 2015
Last Updated: May 16, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Xoft, Inc.:
cervical
cancer
brachytherapy
electronic
external beam radiation therapy (EBRT)
device
applicator
toxicity
gynecologic
high-dose-rate (HDR)
x-ray
safety

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 21, 2017