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

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Treatment	Treatment with Electronic Brachytherapy	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.

Primary Outcome Measures

Name	Time	Method
Safety - Adverse Event Rate and Severity	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

Name	Time	Method
Device Performance	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.