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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851772
• Other study ID #: CTRP-0010
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: Xoft, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Device:
• Treatment with Electronic Brachytherapy

Locations

Country	Name	City	State
United States	Oklahoma University	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Xoft, Inc.	Icad, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of Adverse Events in Participants (i.e.Safety)	To assess occurrence rate of radiation toxicities through three (3) months of follow-up.	3 months post-Study Exit
Primary	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	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)