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

February 4, 2025 updated by: Xoft, Inc.

A Multi-Center Retrospective-Prospective Matched Pairs Cohort Study to Assess Long-term Clinical Outcomes of Non-melanoma Skin Cancer Patients Treated With eBx Compared to Non-melanoma Skin Cancer Patients Treated With Mohs Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

369

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Gatos, California, United States, 95032
        • Kenneth A. Miller, PC
      • San Diego, California, United States, 91910
        • Dermatology & Laser Center of San Diego
      • San Diego, California, United States, 92103
        • Dermatology and Laser Center of San Diego
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Strimling Laser and Vein Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Up to 320 subjects treated with eBx and up to 320 subjects treated with Mohs surgery will have data collected retrospectively from the patient's medical records, and prospectively at the time of the follow-up visit for those who agree to participate in this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Electronic Brachytherapy

Procedure/Surgery: Electronic Brachytherapy:

Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System. High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC).
Procedure: Electronic Brachytherapy
A group receives High-dose-rate electronic brachytherapy (EBT) which provides a non-surgical treatment option and the other group receives Mohs surgery. This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.
Other Names:
  • Mohs Surgery
Mohs Surgery

Previously completed treatment for non-melanoma skin cancer using Mohs Surgery:

Uniquely orients, maps, and processes removed tissue, permitting the microscopic evaluation of virtually 100% of the specimen margins. The completeness of this margin control permits the accurate identification and removal of all tumor extensions under the microscope. Tissues in Mohs surgery are processed as modified frozen sections which allow the accurate and rapid interpretation of most skin cancers.
Procedure: Electronic Brachytherapy
A group receives High-dose-rate electronic brachytherapy (EBT) which provides a non-surgical treatment option and the other group receives Mohs surgery. This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.
Other Names:
  • Mohs Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up
Time Frame: 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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Late Toxicities Related to eBx vs. Mohs Treatment Using A Chronic Toxicity Questionnaire Based on Physician Assessment at Long-term Prospective Visit
Time Frame: 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.
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.
Comparison of Long-term Cosmetic Outcomes for Lesions Treated for NMSC With eBx vs. Mohs
Time Frame: 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.
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.
Chronic Toxicities
Time Frame: 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.
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.
Patient Survey for Reporting Patient Reported Outcomes (PRO)
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xoft, Inc.

Collaborators

Eminence Clinical Research, Inc.

Investigators

  • Principal Investigator: Rakesh Patel, MD, Good Samaritan Radiation Oncology
  • Principal Investigator: Robert Strimling, Strimling Dermatology, Laser, and Vein Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 15, 2017

First Posted (Estimated)

January 19, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTPR-0014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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