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

Xoft, Inc.3 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Cancer

Interventions

Treatment with Electronic BrachytherapyDEVICE

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (1)

Oklahoma University

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

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.

Time frame: Study Exit (90 days)

Secondary Outcomes

Device Performance

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)

Data from ClinicalTrials.gov

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