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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Device: Treatment with Electronic Brachytherapy

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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: Brachytherapy; Xoft®; Axxent®; Electronic; System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Adverse Event Rate and Severity	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.	Study Exit (90 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Performance	Number of subjects who received complete delivery of the brachytherapy treatment using the Xoft Electronic Brachytherapy System with the cervical applicator.	Study Exit (90 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Adverse Events in Participants (i.e.Safety)	To assess occurrence rate of radiation toxicities through three (3) months of follow-up.	3 months post-Study Exit

Collaborators and Investigators

• Sponsor: Xoft, Inc.
• Collaborators: Icad, Inc.
• Investigators: Principal Investigator: Lowndes Harrison, MD, Gadsden Regional Cancer Center

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: May 7, 2013
• First Submitted That Met QC Criteria: May 7, 2013
• First Posted (Estimate): May 10, 2013

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: safety; cancer; device; x-ray; brachytherapy; toxicity; cervical; electronic; gynecologic; applicator; high-dose-rate (HDR); external beam radiation therapy (EBRT)
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: CTRP-0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED