Cervical Cancer
Conditions
Keywords
cervical, cancer, brachytherapy, electronic, device, applicator, toxicity, gynecologic, high-dose-rate (HDR), x-ray, safety, external beam radiation therapy (EBRT)
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.
Interventions
DEVICETreatment with Electronic Brachytherapy
Sponsors
Icad, Inc.
Xoft, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Events in Participants (i.e.Safety) | 3 months post-Study Exit | To assess occurrence rate of radiation toxicities through three (3) months of follow-up. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 45.67 years |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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.
Time frame: Study Exit (90 days)
Population: Diagnosis of locally advanced cervical cancer (Stages Ib2-IVA).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Safety - Adverse Event Rate and Severity | diarrhea-mild | 100 percentage of participants and severity |
| Treatment | Safety - Adverse Event Rate and Severity | fatigue-mild | 100 percentage of participants and severity |
| Treatment | Safety - Adverse Event Rate and Severity | hot flashes-moderate | 100 percentage of participants and severity |
| Treatment | Safety - Adverse Event Rate and Severity | urinary track infection-mild | 33.3 percentage of participants and severity |
| Treatment | Safety - Adverse Event Rate and Severity | vaginal bleeding-mild | 33.3 percentage of participants and severity |
| Treatment | Safety - Adverse Event Rate and Severity | decreased neutrophils-mild | 33.3 percentage of participants and severity |
| Treatment | Safety - Adverse Event Rate and Severity | insomnia-mild | 33.3 percentage of participants and severity |
| Treatment | Safety - Adverse Event Rate and Severity | loss of appetite-mild | 33.3 percentage of participants and severity |
| Treatment | Safety - Adverse Event Rate and Severity | extremity weakness-mild | 33.3 percentage of participants and severity |
| Treatment | Safety - Adverse Event Rate and Severity | mucositis-mild | 33.3 percentage of participants and severity |
| Treatment | Safety - Adverse Event Rate and Severity | urinary frequency-mild | 33.3 percentage of participants and severity |
| Treatment | Safety - Adverse Event Rate and Severity | weight loss-mild | 33.3 percentage of participants and severity |
| Treatment | Safety - Adverse Event Rate and Severity | headache-moderate | 33.3 percentage of participants and severity |
| Treatment | Safety - Adverse Event Rate and Severity | chest pressure-moderate | 33.3 percentage of participants and severity |
| Treatment | Safety - Adverse Event Rate and Severity | light headed-moderate | 33.3 percentage of participants and severity |
| Treatment | Safety - Adverse Event Rate and Severity | mild skin erythema-mild | 33.3 percentage of participants and severity |
| Treatment | Safety - Adverse Event Rate and Severity | occasional burning with urination-mild | 33.3 percentage of participants and severity |
Secondary
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Device Performance | 3 participants |
Other Pre-specified
Frequency of Adverse Events in Participants (i.e.Safety)
To assess occurrence rate of radiation toxicities through three (3) months of follow-up.
Time frame: 3 months post-Study Exit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Frequency of Adverse Events in Participants (i.e.Safety) | 3 participants |