N/A
N=183
Post-market Multi-Center RETRO-Prospective Study to Assess Long-term Clinical Outcomes NMSC Patients Treated With eBx
Non-melanoma Skin Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05257486 ↗Enrolled (actual)
183
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Local Recurrence — 2 Lesions
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Xoft eBx (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Xoft, Inc.
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Recurrence |
2 | — |
| SECONDARY Skin Toxicities |
129 | — |
Summary
The purpose of this retrospective-prospective study is to evaluate lesions after treatment for BCC or SCC NMSC in order to gain a better understanding of the durability of the treatment, and risk of late toxicities for this patient population.
Eligibility Criteria
Inclusion Criteria
- Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System according to standard of care;16
- Provides informed consent;
- Greater than 40 years of age;
- Pathological diagnosis confirmed to be squamous cell carcinoma, or squamous cell carcinoma-in-situ, or basal cell carcinoma prior to treatment;
- Cancer Staging included in this study:
Stage 0: Tis, N0, M0 Stage 1: T1a, b, c, N0, M0 Stage 2: T2a, N0, M0
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;
- Lesion treated with Mohs surgery.
Data sourced from ClinicalTrials.gov (NCT05257486). 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.