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 Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer|
- Safety [ Time Frame: 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.
- Device Performance [ Time Frame: 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.
- Frequency of Adverse Events in Participants (i.e.Safety) [ Time Frame: 3 months post-Study Exit ]To assess occurrence rate of radiation toxicities through three (3) months of follow-up.
|Study Start Date:||November 2013|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01851772
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Lowndes Harrison, MD||Gadsden Regional Cancer Center|