Trial Outcomes & Findings for Post-market Multi-Center RETRO-Prospective Study to Assess Long-term Clinical Outcomes NMSC Patients Treated With eBx (NCT NCT05257486)

Last Updated: 2025-01-13

Results Overview

Physician office visit for long-term assessment to determine if recurrence of skin cancer has occurred at previously treated site for subjects who were previously treated at least 5 years prior; Subjects treated with Xoft eBx or MMS over 5 years prior were called in for a long-term prospective visit, reconsented, and assessed for skin cancer recurrence at the previously treated site.

Recruitment status

COMPLETED

Target enrollment

183 participants

Primary outcome timeframe

Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion.

Results posted on

2025-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	NMSC Treatment Patients who completed Xoft eBx treatment at least five years from the last treatment. Xoft eBx: The Xoft Axxent Electronic Brachytherapy (eBx) System allows for the administration of high dose rate brachytherapy treatments using an electronic source
Overall Study STARTED	183
Overall Study COMPLETED	180
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	NMSC Treatment Patients who completed Xoft eBx treatment at least five years from the last treatment. Xoft eBx: The Xoft Axxent Electronic Brachytherapy (eBx) System allows for the administration of high dose rate brachytherapy treatments using an electronic source
Overall Study Protocol Violation	3

Baseline Characteristics

Post-market Multi-Center RETRO-Prospective Study to Assess Long-term Clinical Outcomes NMSC Patients Treated With eBx

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NMSC Treatment n=180 Participants Retrospective review to find subjects post Xoft eBx treatment completed at least 5 years ago to complete 1 long-term prospective visit. Xoft eBx: The Xoft Axxent Electronic Brachytherapy (eBx) System allows for the administration of high dose rate brachytherapy treatments using an electronic source
Age, Continuous	82.3 Year STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants
Sex: Female, Male Male	111 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	176 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	178 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	180 Participants n=5 Participants

PRIMARY outcome

Timeframe: Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion.

Population: 180 Patients that completed eBx treatment with at least 5 Year follow-up

Outcome measures

Outcome measures
Measure	NMSC Treatment n=182 Lesions Patients who completed Xoft eBx treatment at least five years from the last treatment. Xoft eBx: The Xoft Axxent Electronic Brachytherapy (eBx) System allows for the administration of high dose rate brachytherapy treatments using an electronic source
Local Recurrence	2 Lesions

SECONDARY outcome

Timeframe: Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion.

Population: Patients who completed Xoft eBx treatment at least five year follow-up

Assessment of treatment site at a long-term follow-up visit conducted at 5 years or greater post treatment to determine if late toxicities have occurred at the previously treated site where either eBx or Mohs was performed. Subjects treated with Xoft eBx or MMS over 5 years prior were called in for a long-term prospective visit, reconsented, and assessed for late toxicities at the previously treated site.

Outcome measures

Outcome measures
Measure	NMSC Treatment n=180 Participants Patients who completed Xoft eBx treatment at least five years from the last treatment. Xoft eBx: The Xoft Axxent Electronic Brachytherapy (eBx) System allows for the administration of high dose rate brachytherapy treatments using an electronic source
Skin Toxicities	129 Participants

Adverse Events

NMSC Treatment

Serious events: 0 serious events

Other events: 129 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	NMSC Treatment n=180 participants at risk Patients who completed Xoft eBx treatment at least five years from the last treatment. Xoft eBx: The Xoft Axxent Electronic Brachytherapy (eBx) System allows for the administration of high dose rate brachytherapy treatments using an electronic source
Skin and subcutaneous tissue disorders Hypopigmentation Grade 1	66.7% 120/180 • Number of events 120 • Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion. Select Skin toxicity adverse events according to CTCAE.
Skin and subcutaneous tissue disorders Telangiectasia Grade 1	22.8% 41/180 • Number of events 41 • Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion. Select Skin toxicity adverse events according to CTCAE.
Skin and subcutaneous tissue disorders Scar Grade 1	1.1% 2/180 • Number of events 2 • Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion. Select Skin toxicity adverse events according to CTCAE.
Skin and subcutaneous tissue disorders Hyperpigmentation Grade 1	1.1% 2/180 • Number of events 2 • Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion. Select Skin toxicity adverse events according to CTCAE.
Skin and subcutaneous tissue disorders Induration Grade 2	0.56% 1/180 • Number of events 1 • Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion. Select Skin toxicity adverse events according to CTCAE.

Additional Information

Robert Burnside

Xoft, Inc.

Phone: 14084931533

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place