Comparison of eBX and Mohs Surgery for Treatment of Early-stage Non-melanoma Skin Cancer a Matched Pair Cohort Study.

Completed

• Conditions: Nonmelanoma Skin Cancer

• Registration Number: NCT03024866
• Lead Sponsor: Xoft, Inc.

Brief 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.

Detailed Description

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. The study will include 2 parts:

1. Retrospective chart review: Collect data from patient records who completed treatment a minimum of 2 years prior to study onset and determine the feasibility of doing a matched pair cohort study comparison of eBx versus Mohs surgery. The history, demographic and treatment data will be retrospectively collected from up to 320 subjects previously treated with eBx for the treatment of NMSC and up to 320 subjects previously treated with Mohs surgery for the treatment of NMSC.

2. Prospective Follow-up: Patients will return for long-term follow-up visits for the investigators to assess the lesion site, document absence of recurrence/ absence of recurrence, toxicities, and collect patient reported outcomes.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-15
• Study First Posted: 2017-01-19
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Results First Submitted: 2018-03-20
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-04
• Last Update Submitted: 2025-02-04
• Results First Posted: 2025-03-25
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 369

Inclusion Criteria

1. Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System or Mohs surgery;

2. Provides informed Consent;

3. Greater than 40 years of age;

4. Pathological diagnosis confirmed to be squamous cell or basal cell carcinoma prior to treatment;

5. 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

1. Target area is adjacent to a burn scar
2. Any prior definitive surgical resection of the cancer, prior to Radiation Treatment
3. Known perineural invasion
4. Actinic Keratosis
5. Known spread to regional lymph nodes
6. Known metastatic disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of Late Toxicities Related to eBx vs. Mohs Treatment Using A Chronic Toxicity Questionnaire Based on Physician Assessment at Long-term Prospective Visit	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.
Comparison of Long-term Cosmetic Outcomes for Lesions Treated for NMSC With eBx vs. Mohs	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.
Chronic Toxicities	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 there were any chronic toxicities found at the previously treated site with Xoft eBx or MMS.
Patient Survey for Reporting Patient Reported Outcomes (PRO)	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.

Trial Locations

Locations (4)

Kenneth A. Miller, PC; 🇺🇸 Los Gatos, California, United States

Dermatology & Laser Center of San Diego; 🇺🇸 San Diego, California, United States

Dermatology and Laser Center of San Diego; 🇺🇸 San Diego, California, United States

Strimling Laser and Vein Institute; 🇺🇸 Las Vegas, Nevada, United States