Clinical trial NCT03024866: Comparison of eBX and Mohs Surgery for Treatment of Early-stage Non-melanoma Skin Cancer a Matched Pair Cohort Study.
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonmelanoma Skin Cancer
Lead sponsor: Xoft, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eminence Clinical Research, Inc.
First posted: 2017-01-19
Enrollment: 369
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up
timeFrame: 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:
measure: Comparison of Late Toxicities Related to eBx vs. Mohs Treatment Using A Chronic Toxicity Questionnaire Based on Physician Assessment at Long-term Prospective Visit
timeFrame: 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.
measure: Comparison of Long-term Cosmetic Outcomes for Lesions Treated for NMSC With eBx vs. Mohs
timeFrame: 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.
measure: Chronic Toxicities
timeFrame: 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.
measure: Patient Survey for Reporting Patient Reported Outcomes (PRO)
timeFrame: 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.
Other outcomes:
Locations:
city: Los Gatos
country: United States
facility: Kenneth A. Miller, PC
state: California
city: San Diego
country: United States
facility: Dermatology & Laser Center of San Diego
state: California
city: San Diego
country: United States
facility: Dermatology and Laser Center of San Diego
state: California
city: Las Vegas
country: United States
facility: Strimling Laser and Vein Institute
state: Nevada
Study officials:
affiliation: Good Samaritan Radiation Oncology
name: Rakesh Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Strimling Dermatology, Laser, and Vein Institute
name: Robert Strimling
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.