Electronic Brachytherapy (eBx)-Mohs Matched Pair - Cohort Study 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: Unknown
• Conditions: Nonmelanoma Skin Cancer

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 (Anticipated): 500

Contacts and Locations

• Study Contact: Name: John DeLucia; Phone Number: 603-546-7430; Email: jdelucia@icadmed.com
• Study Contact Backup: Name: Joyce Musacchio; Phone Number: 7308 603-882-5200; Email: jmusacchio@icadmed.com

Study Locations

• United States
  • California
    • Los Gatos, California, United States, 95032
      • Active, not recruiting
      • Kenneth A. Miller, PC
    • San Diego, California, United States, 91910
      • Recruiting
      • Dermatology & Laser Center of San Diego
      • Contact: Mark Willoughby, MD; Phone Number: 619-754-8469; Email: willoughby_mark@hotmail.com
    • San Diego, California, United States, 92103
      • Recruiting
      • Dermatology and Laser Center of San Diego
      • Contact: Mark Willoughby, MD; Phone Number: 619-320-4807; Email: willoughby_mark@hotmail.com
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Recruiting
      • Strimling Laser and Vein Institute
      • Contact: Jamie Butler; Phone Number: 702-243-6400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Electronic Brachytherapy; Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System
Mohs Surgery; Previously completed treatment for non-melanoma skin cancer using Mohs Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of local recurrence at approximately 3 to 5-year follow-up (range is approximately two to five years) at treatment site(s).	Assessment of treatment site 2-5 years following treatment to determine if recurrence	Two to five years post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of long-term toxicities related to eBx vs. Mohs treatment Using A Chronic Toxicity Questionnaire Based om Physician Assessment at Time of Visit	Assessment of treatment site 2-5 years following treatment to determine if long-term toxicity	Two to five years post treatment
Comparison of long-term cosmetic outcomes for lesions treated for NMSC with eBx vs. Mohs;	Physician assessment of cosmetic outcome two to five years post treatment, at time of clinic visit.	Two to five years post treatment
Chronic toxicities	Physician assessment of treatment site to assess for chronic toxicites two to five years post treatment, at time of clinic visit.	Two to five years post treatment
Patient Survey for reporting Patient Reported Outcomes (PRO)	Patient completes a survey at a clinic visit two to five years post treatment at time of clinic visit	Two to five years post treatment

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 15, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Estimate): January 19, 2017
• Last Update Submitted That Met QC Criteria: January 15, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: CTPR-0014