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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Device: Treatment with Electronic Brachytherapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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<br> <br> * Other names: System;|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical, cancer, brachytherapy, electronic, device, applicator, toxicity, gynecologic, high-dose-rate (HDR), x-ray, safety, external beam radiation therapy (EBRT)