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

Nonmelanoma Skin Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03024866
• Other study ID #: CTPR-0014
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2017
• Last updated: January 15, 2017
• Start date: October 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2017
• Source: Xoft, Inc.
• Contact: John DeLucia
• Phone: 603-546-7430
• Email: jdelucia[@]icadmed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 41 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nonmelanoma Skin Cancer
• Skin Neoplasms

Locations

Country	Name	City	State
United States	Strimling Laser and Vein Institute	Las Vegas	Nevada
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Xoft, Inc.	Eminence Clinical Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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