Back to results

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

Primary Purpose

Cervical Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Treatment with Electronic Brachytherapy

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring cervical, cancer, brachytherapy, electronic, device, applicator, toxicity, gynecologic, high-dose-rate (HDR), x-ray, safety, external beam radiation therapy (EBRT)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Oklahoma University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Device Performance

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

Full Information

NCT ID

NCT01851772

First Posted

May 7, 2013

Last Updated

December 22, 2020

Sponsor

Xoft, Inc.

Collaborators

Icad, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01851772

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xoft, Inc.

Collaborators

Icad, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Treatment with Electronic Brachytherapy

Other Intervention Name(s)

Xoft®, Axxent®, Electronic, Brachytherapy, System

Primary Outcome Measure Information:

Title

Safety - Adverse Event Rate and Severity

Description

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.

Time Frame

Study Exit (90 days)

Secondary Outcome Measure Information:

Title

Device Performance

Description

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

Time Frame

Study Exit (90 days)

Other Pre-specified Outcome Measures:

Title

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

Description

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

Time Frame

3 months post-Study Exit

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lowndes Harrison, MD

Organizational Affiliation

Gadsden Regional Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oklahoma University

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs