An interventional study of Electronic brachytherapy (Axxent System) in Breast Cancer, sponsored by Xoft, Inc.. Completed at 10 sites in United States. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2020-08-13.
Sponsored by Xoft, Inc. · Not applicable, Interventional, and Treatment
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System for the delivery of radiation therapy as part of breast conserving therapy in women with resected, early stage breast cancer.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 44 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Xoft, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This is a single arm study where all patients are treated with FDA cleared electronic brachytherapy treatment.
Radiation: Electronic brachytherapy (Axxent System)
3.4 Gy per fraction for 10 fractions for a total of 34 Gy.
Also known as: Radiation therapy, Axxent, Xoft, eBx, EBT, brachytherapy
Number of Participants With Delivery of 34 Gy in 10 Fractions
Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue)
Time frame: measured at end of 10th fraction, usually within 7 days
Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up.
Serious adverse device related events reported from treatment through 6 month follow-up and at 5-year follow-up are reported.
Time frame: Through 6 months
Hospitals with radiation oncology departments who had acquired the Xoft Axxent system and were qualified to be in the study were chosen as the 10 sites. Breast surgeons and radiation oncologists were the site investigators at 10 sites.
| Milestone | Electronic Brachytherapy |
|---|---|
| Started | 44 |
| Completed | 43 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
| Milestone | Electronic Brachytherapy |
|---|---|
| Started | 43 |
| Completed | 36 |
| Not completed | 7 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 5 |
| Milestone | Electronic Brachytherapy |
|---|---|
| Started | 36 |
| Completed | 24 |
| Not completed | 12 |
| Withdrew: Lost to follow-up | 9 |
| Withdrew: Mastectomy | 3 |
Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue)
| Participants | Electronic Brachytherapy |
|---|---|
| Number of Participants With Delivery of 34 Gy in 10 Fractions | 42 |
Serious adverse device related events reported from treatment through 6 month follow-up and at 5-year follow-up are reported.
| events | Electronic Brachytherapy |
|---|---|
| Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up. | 0 |
Collected over Treatment through 5 Year Follow-up.. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Electronic Brachytherapy | — | 0/44 (0%) | 22/44 (50%) |
| Event | Electronic Brachytherapy |
|---|---|
| SeromaSkin and subcutaneous tissue disorders | 9/44 |
| ErythemaSkin and subcutaneous tissue disorders | 8/44 |
| PainReproductive system and breast disorders | 5/44 |
| InfectionInfections and infestations | 5/44 |
| HyperpigmentationSkin and subcutaneous tissue disorders | 3/44 |
| Moist desquamationSkin and subcutaneous tissue disorders | 2/44 |
| Age, Continuous(years) | Electronic Brachytherapy |
|---|---|
| Mean | 64 ± 8.24 |
| Age, Customized(participants) | Electronic Brachytherapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 50 years | 2 |
| >=50 years | 42 |
| Sex: Female, Male(Participants) | Electronic Brachytherapy |
|---|---|
| Female | 44 |
| Male | 0 |
| Region of Enrollment(participants) | Electronic Brachytherapy |
|---|---|
| United States | 44 |
Plan to share: No
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Xoft, Inc.