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

NCT03024866 | Completed Results

• 1 other identifier: CTPR-0014
• Study Type: observational
• Target: 369
• Locations: 1 country
• Sites: 4

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.

Conditions

Nonmelanoma Skin Cancer

Outcome Measures

Primary Outcomes (1)

• Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up

  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 Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

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

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

Interventions

Electronic Brachytherapy PROCEDURE

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.

Also known as: Mohs Surgery

Electronic Brachytherapy; Mohs Surgery

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xoft, Inc.: lead
• Eminence Clinical Research, Inc.: collaborator

Study Sites (4)

Kenneth A. Miller, PC

Los Gatos, California, 95032, United States

Location

Dermatology & Laser Center of San Diego

San Diego, California, 91910, United States

Location

Dermatology and Laser Center of San Diego

San Diego, California, 92103, United States

Location

Strimling Laser and Vein Institute

Las Vegas, Nevada, 89144, United States

Location

Related Publications (1)

• Patel R, Strimling R, Doggett S, Willoughby M, Miller K, Dardick L, Mafong E. Comparison of electronic brachytherapy and Mohs micrographic surgery for the treatment of early-stage non-melanoma skin cancer: a matched pair cohort study. J Contemp Brachytherapy. 2017 Aug;9(4):338-344. doi: 10.5114/jcb.2017.68480. Epub 2017 Jun 23.

  PMID: 28951753 RESULT

MeSH Terms

Interventions

Mohs Surgery

Intervention Hierarchy (Ancestors)

Microsurgery; Surgical Procedures, Operative; Dermatologic Surgical Procedures; Plastic Surgery Procedures

Results Point of Contact

• Title: Robert Burnside
• Organization: Xoft Inc.

rob.burnside@elekta.com

14084931533

Study Officials

• Rakesh Patel, MD

  Good Samaritan Radiation Oncology

  PRINCIPAL INVESTIGATOR

• Robert Strimling

  Strimling Dermatology, Laser, and Vein Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 19, 2017
• Study Start: October 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2025-02

Locations

US (4)