Trial Outcomes & Findings for Comparison of eBX and Mohs Surgery for Treatment of Early-stage Non-melanoma Skin Cancer a Matched Pair Cohort Study. (NCT NCT03024866)
NCT ID: NCT03024866
Last Updated: 2025-02-06
Results Overview
Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed for skin cancer recurrence at the previously treated site.
Recruitment status
COMPLETED
Target enrollment
369 participants
Primary outcome timeframe
Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.
Results posted on
2025-02-06
Participant Flow
Identify and collect any existing data from the patients record and conduct office visits on patients with non-melanoma skin cancer who underwent treatment with either eBx or Mohs and completed treatment approximately 3 yrs prior (range of 2-4 years) to asses long-term outcomes of treated areas.
N/A This is a retrospective-prospective study design.
Participant milestones
| Measure |
Mohs Surgery
Previously completed treatment for non-melanoma skin cancer using Mohs Surgery
|
Electronic Brachytherapy
Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System
|
|---|---|---|
|
Overall Study
STARTED
|
181
|
188
|
|
Overall Study
Completed Enrollment
|
181
|
188
|
|
Overall Study
COMPLETED
|
181
|
188
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of eBX and Mohs Surgery for Treatment of Early-stage Non-melanoma Skin Cancer a Matched Pair Cohort Study.
Baseline characteristics by cohort
| Measure |
Electronic Brachytherapy
n=208 Lesions Analyzed
Previously completed treatment of 1 or more non-melanoma skin cancer lesions per participant using Xoft eBx Electronic Brachytherapy System
|
Mohs Surgery
n=208 Lesions Analyzed
Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Mohs Surgery
|
Total
n=416 Lesions Analyzed
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
eBx
|
80.8 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
76.6 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
78.7 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
65 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
123 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian Non-Hispanic
|
186 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
366 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Lesions by Size
Lesions less than 1cm
|
57 lesions
n=208 Lesions Analyzed
|
57 lesions
n=208 Lesions Analyzed
|
114 lesions
n=416 Lesions Analyzed
|
|
Lesions by Size
Lesions greater than 1cm less than 2cm
|
146 lesions
n=208 Lesions Analyzed
|
146 lesions
n=208 Lesions Analyzed
|
292 lesions
n=416 Lesions Analyzed
|
|
Lesions by Size
Lesions greater than 2cm less than 3cm
|
5 lesions
n=208 Lesions Analyzed
|
5 lesions
n=208 Lesions Analyzed
|
10 lesions
n=416 Lesions Analyzed
|
PRIMARY outcome
Timeframe: Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed for skin cancer recurrence at the previously treated site.
Outcome measures
| Measure |
Electronic Brachytherapy
n=208 Lesions Analyzed
Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System
Electronic Brachytherapy: High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC). This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.
|
Mohs Surgery
n=208 Lesions Analyzed
Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Mohs Surgery
Electronic Brachytherapy: High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC). This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.
|
|---|---|---|
|
Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up
Participants Analyzed
|
188 participants
|
181 participants
|
|
Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up
Absence of Local Recurrence
|
187 participants
|
181 participants
|
|
Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up
Lesions Analyzed
|
208 participants
|
208 participants
|
SECONDARY outcome
Timeframe: Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed to determine if late toxicities occurred at the previously treated site with Xoft eBx or MMS.
Outcome measures
| Measure |
Electronic Brachytherapy
n=208 Lesions Analyzed
Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System
Electronic Brachytherapy: High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC). This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.
|
Mohs Surgery
n=208 Lesions Analyzed
Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Mohs Surgery
Electronic Brachytherapy: High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC). This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.
|
|---|---|---|
|
Comparison of Late Toxicities Related to eBx vs. Mohs Treatment Using A Chronic Toxicity Questionnaire Based on Physician Assessment at Long-term Prospective Visit
|
138 lesions
|
143 lesions
|
SECONDARY outcome
Timeframe: Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and an assessment of cosmetic outcome occurred at the previously treated site with Xoft eBx or MMS.
Outcome measures
| Measure |
Electronic Brachytherapy
n=208 Lesions Analyzed
Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System
Electronic Brachytherapy: High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC). This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.
|
Mohs Surgery
n=208 Lesions Analyzed
Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Mohs Surgery
Electronic Brachytherapy: High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC). This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.
|
|---|---|---|
|
Comparison of Long-term Cosmetic Outcomes for Lesions Treated for NMSC With eBx vs. Mohs
|
203 lesions
|
199 lesions
|
SECONDARY outcome
Timeframe: Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.Population: Analysis same as late toxicities.
Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed to determine if there were any chronic toxicities found at the previously treated site with Xoft eBx or MMS.
Outcome measures
| Measure |
Electronic Brachytherapy
n=208 Lesions Analyzed
Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System
Electronic Brachytherapy: High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC). This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.
|
Mohs Surgery
n=208 Lesions Analyzed
Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Mohs Surgery
Electronic Brachytherapy: High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC). This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.
|
|---|---|---|
|
Chronic Toxicities
|
138 Lesions Analyzed
|
143 Lesions Analyzed
|
SECONDARY outcome
Timeframe: Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start, with 1 long-term prospective visit by study completion.Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, then subjects completed a Patient Satisfaction Score: min=0, max=60, with 60 as the maximum positive or favorable response.
Outcome measures
| Measure |
Electronic Brachytherapy
n=188 Participants
Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System
Electronic Brachytherapy: High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC). This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.
|
Mohs Surgery
n=181 Participants
Previously completed treatment of 1 or more lesions per participant for non-melanoma skin cancer using Mohs Surgery
Electronic Brachytherapy: High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC). This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.
|
|---|---|---|
|
Patient Survey for Reporting Patient Reported Outcomes (PRO)
|
54.0 score on a scale
Standard Deviation 9.0
|
56.0 score on a scale
Standard Deviation 5.3
|
Adverse Events
Mohs Surgery
Serious events: 0 serious events
Other events: 79 other events
Deaths: 0 deaths
Electronic Brachytherapy
Serious events: 0 serious events
Other events: 107 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mohs Surgery
n=181 participants at risk
Previously completed treatment for non-melanoma skin cancer using Mohs Surgery
|
Electronic Brachytherapy
n=188 participants at risk
Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Late toxicities
|
43.6%
79/181 • Number of events 181 • Patients have been followed for 2.6 to 4.3 years after EBT, and 2.3 to 5 years following MMS.
All additional adverse events that were collected have been reported. The only adverse events reported were all skin toxicities from CTCAE.
|
56.9%
107/188 • Number of events 188 • Patients have been followed for 2.6 to 4.3 years after EBT, and 2.3 to 5 years following MMS.
All additional adverse events that were collected have been reported. The only adverse events reported were all skin toxicities from CTCAE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place