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

Xoft

Status: Completed

Conditions: Cervical Cancer

Treatments: Device: Treatment with Electronic Brachytherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01851772

CTRP-0010

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Treatment

Experimental group

Description:

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.

Treatment:

Device: Treatment with Electronic Brachytherapy