Post-market Multi-Center RETRO-Prospective Study to Assess Long-term Clinical Outcomes NMSC Patients Treated With eBx

Completed

Brief Summary: The purpose of this retrospective-prospective study is to evaluate lesions after treatment for BCC or SCC NMSC in order to gain a better understanding of the durability of the treatment, and risk of late toxicities for this patient population.

Detailed Description: This is a retrospective-prospective study design. The study is post-market, on-label observational study for the treatment of NMSC. Patients who completed treatment at least five years from the last treatment will be identified and existing data as required by this protocol in the patient's record will be collected in addition to conducting office visits or telehealth visits (video) for long-term follow-up.

The study will include:

Identifying patients, retrospectively, who completed treatment a minimum of five years from the last treatment. The history and demographic data will be collected from up to 300 subjects previously treated with eBx for the treatment of NMSC. Patients will have an office visit or telehealth visit in order for the investigators to assess the lesion site, document absence of recurrence, treatment for recurrence (if applicable), and long-term toxicities at the time of the prospective visit.

Recruitment & Eligibility

Inclusion Criteria

Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System according to standard of care;16
Provides informed consent;
Greater than 40 years of age;
Pathological diagnosis confirmed to be squamous cell carcinoma, or squamous cell carcinoma-in-situ, or basal cell carcinoma prior to treatment;
Cancer Staging included in this study:

Stage 0: Tis, N0, M0 Stage 1: T1a, b, c, N0, M0 Stage 2: T2a, N0, M0

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;
Lesion treated with Mohs surgery.

Arm && Interventions

Group	Intervention	Description
NMSC Treatment	Xoft eBx	Patients who completed Xoft eBx treatment at least five years from the last treatment.

Primary Outcome Measures

Name	Time	Method
Local Recurrence	Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion.	Physician office visit for long-term assessment to determine if recurrence of skin cancer has occurred at previously treated site for subjects who were previously treated at least 5 years prior; Subjects treated with Xoft eBx or MMS over 5 years prior were called in for a long-term prospective visit, reconsented, and assessed for skin cancer recurrence at the previously treated site.

Secondary Outcome Measures

Name	Time	Method
Skin Toxicities	Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion.	Assessment of treatment site at a long-term follow-up visit conducted at 5 years or greater post treatment to determine if late toxicities have occurred at the previously treated site where either eBx or Mohs was performed. Subjects treated with Xoft eBx or MMS over 5 years prior were called in for a long-term prospective visit, reconsented, and assessed for late toxicities at the previously treated site.

Locations (2): Kenneth A. Miller, MD Dermatology
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Campbell, California, United States
Dermatology & Laser Center of San Diego
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San Diego, California, United States