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

NCT01851772 | Completed Results

• 1 other identifier: CTRP-0010
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer

Keywords

cervical; cancer; brachytherapy; electronic; device; applicator; toxicity; gynecologic; high-dose-rate (HDR); x-ray; safety; external beam radiation therapy (EBRT)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Device Performance

  Study Exit (90 days)

Other Outcomes (1)

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

  3 months post-Study Exit

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

Treatment with Electronic Brachytherapy DEVICE

Also known as: Xoft®, Axxent®, Electronic, Brachytherapy, System

Treatment

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Xoft, Inc.: lead
• Icad, Inc.: collaborator

Study Sites (1)

Oklahoma University

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasms

Interventions

Therapeutics; Brachytherapy; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Drug Therapy

Results Point of Contact

• Title: Crystal Leonard, CCRP
• Organization: Xoft, Inc.

cleonard@icadmed.com

9375038588

Study Officials

• Lowndes Harrison, MD

  Gadsden Regional Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 10, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 12, 2021
• Results First Posted: June 24, 2016

Record last verified: 2015-11

Locations

US (1)