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Completed

NCT Number: NCT03024866

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

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.

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Key information

Age range

41 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kenneth A. Miller, PC, Los Gatos, California, United States

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About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Mohs Surgery

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Xoft, Inc.

Industry

Collaborators

  • Eminence Clinical Research, Inc.

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 19, 2017
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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