Trial Outcomes & Findings for Post Market Study Using the Xoft Axxent System (NCT NCT01017549)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

measured at end of 10th fraction, usually within 7 days

Results posted on

2020-08-13

Participant Flow

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.

This was a single arm study, no randomization. Some patients consented but fell out of the study due to not meeting all eligibility (I/E) criteria after consenting to participation. 61 patients provided consent, 44 were treated.

Participant milestones

Participant milestones
Measure	Electronic Brachytherapy Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
Eligibility Through 6 Month Follow-up STARTED	44
Eligibility Through 6 Month Follow-up COMPLETED	43
Eligibility Through 6 Month Follow-up NOT COMPLETED	1
One-year Follow-up STARTED	43
One-year Follow-up COMPLETED	36
One-year Follow-up NOT COMPLETED	7
5 Year Follow-up STARTED	36
5 Year Follow-up COMPLETED	24
5 Year Follow-up NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Electronic Brachytherapy Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
Eligibility Through 6 Month Follow-up Lost to Follow-up	1
One-year Follow-up Lost to Follow-up	2
One-year Follow-up Withdrawal by Subject	5
5 Year Follow-up Lost to Follow-up	9
5 Year Follow-up Mastectomy	3

Baseline Characteristics

Post Market Study Using the Xoft Axxent System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electronic Brachytherapy n=44 Participants Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
Age, Continuous	64 years STANDARD_DEVIATION 8.24 • n=5 Participants
Age, Customized <=18 years	0 participants n=5 Participants
Age, Customized Between 18 and 50 years	2 participants n=5 Participants
Age, Customized >=50 years	42 participants n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants

PRIMARY outcome

Timeframe: measured at end of 10th fraction, usually within 7 days

Population: All patients treated were analyzed

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)

Outcome measures

Outcome measures
Measure	Electronic Brachytherapy n=44 Participants Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
Number of Participants With Delivery of 34 Gy in 10 Fractions	42 Participants

SECONDARY outcome

Timeframe: Through 6 months

Population: All patients treated were analyzed at 6 months except for 1 patient who was lost to follow-up.

Serious adverse device related events reported from treatment through 6 month follow-up and at 5-year follow-up are reported.

Outcome measures

Outcome measures
Measure	Electronic Brachytherapy n=44 Participants Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up.	0 events

Adverse Events

Electronic Brachytherapy

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Electronic Brachytherapy n=44 participants at risk Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
Skin and subcutaneous tissue disorders Erythema	18.2% 8/44 • Number of events 8 • Treatment through 5 Year Follow-up. Common Terminology Criteria V3 was used to report Adverse Events in this study.
Reproductive system and breast disorders Pain	11.4% 5/44 • Number of events 5 • Treatment through 5 Year Follow-up. Common Terminology Criteria V3 was used to report Adverse Events in this study.
Skin and subcutaneous tissue disorders Hyperpigmentation	6.8% 3/44 • Number of events 3 • Treatment through 5 Year Follow-up. Common Terminology Criteria V3 was used to report Adverse Events in this study.
Skin and subcutaneous tissue disorders Moist desquamation	4.5% 2/44 • Number of events 2 • Treatment through 5 Year Follow-up. Common Terminology Criteria V3 was used to report Adverse Events in this study.
Infections and infestations Infection	11.4% 5/44 • Number of events 5 • Treatment through 5 Year Follow-up. Common Terminology Criteria V3 was used to report Adverse Events in this study.
Skin and subcutaneous tissue disorders Seroma	20.5% 9/44 • Number of events 9 • Treatment through 5 Year Follow-up. Common Terminology Criteria V3 was used to report Adverse Events in this study.

Additional Information

Michael A. Patz MBA, RAC, Senior Director Clinical Affairs

iCAD, Inc. Xoft, Inc

Phone: 603-882-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The results are published; therefore the disclosure agreement is no longer in effect. The site investigators were to ask permission to publish single center results if they chose to publish prior to the entire study results were published.
Publication restrictions are in place

Restriction type: OTHER