N/A
N=369
Comparison of eBX and Mohs Surgery for Treatment of Early-stage Non-melanoma Skin Cancer a Matched Pair Cohort Study.
Nonmelanoma Skin Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03024866 ↗Enrolled (actual)
369
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up — 188; 181; 187; 181 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Electronic Brachytherapy (Procedure)
- Age
- Adult, Older Adult · 41+ yrs
- Sex
- All
- Sponsor
- Xoft, Inc.
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up |
188; 181; 187; 181; 208; 208 | — |
| SECONDARY 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; 143 | — |
| SECONDARY Comparison of Long-term Cosmetic Outcomes for Lesions Treated for NMSC With eBx vs. Mohs |
203; 199 | — |
| SECONDARY Chronic Toxicities |
138; 143 | — |
| SECONDARY Patient Survey for Reporting Patient Reported Outcomes (PRO) |
54.0; 56.0 | — |
Summary
This is a retrospective-prospective study design. Patients who completed treatment approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be identified and any existing data in the patient's record will be collected in addition to conducting office visits for long-term follow-up.
Eligibility Criteria
Inclusion Criteria
- Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System or Mohs surgery;
- Provides informed Consent;
- Greater than 40 years of age;
- Pathological diagnosis confirmed to be squamous cell or basal cell carcinoma prior to treatment;
- Cancer Staging included in this study:
- Stage 0: Tis, N0, M0
- Stage 1: T1, N0, M0
- Stage 2: T2, N0, M0 and ≤ 4cm in diameter
Exclusion Criteria
- Target area is adjacent to a burn scar
- Any prior definitive surgical resection of the cancer, prior to Radiation Treatment
- Known perineural invasion
- Actinic Keratosis
- Known spread to regional lymph nodes
- Known metastatic disease
Data sourced from ClinicalTrials.gov (NCT03024866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.