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| Name | Class |
|---|---|
| Icad, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with Electronic Brachytherapy | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Lowndes Harrison, MD | Gadsden Regional Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma University | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Diagnosis of locally advanced cervical cancer (Stages Ib2-IVA). | Posted | Number | percentage of participants and severity | Study Exit (90 days) |
|
|
The type, number and severity of Adverse Events from the time of cervical brachytherapy treatment through three months follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Crystal Leonard, CCRP | Xoft, Inc. | 9375038588 | cleonard@icadmed.com |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D001918 | Brachytherapy |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D004358 | Drug Therapy |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Device Performance | Number of subjects who received complete delivery of the brachytherapy treatment using the Xoft Electronic Brachytherapy System with the cervical applicator. | Posted | Number | participants | Study Exit (90 days) |
|
|
|
| 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. | Posted | Number | participants | 3 months post-Study Exit |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| Fatigue | General disorders | Systematic Assessment |
|
| Hoareseness | General disorders | Systematic Assessment |
|
| Hot Flashes | General disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment | Urinary Tract Infection |
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| Vaginal Bleeding | Reproductive system and breast disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Mucositis | Infections and infestations | Systematic Assessment |
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| Chest Pressure | Cardiac disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D002577 |
| Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |