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

Xoft

Status: Completed

Conditions: Non-melanoma Skin Cancer

Treatments: Device: Xoft eBx

Study type: Observational

Funder types: Industry

Identifiers

NCT05257486

CTPR-0019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 183 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System according to standard of care;16
2. Provides informed consent;
3. Greater than 40 years of age;
4. Pathological diagnosis confirmed to be squamous cell carcinoma, or squamous cell carcinoma-in-situ, or basal cell carcinoma prior to treatment;
5. 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

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;
7. Lesion treated with Mohs surgery.

Trial design

183 participants in 1 patient group

NMSC Treatment

Description:

Patients who completed Xoft eBx treatment at least five years from the last treatment.

Treatment:

Device: Xoft eBx