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

Non-melanoma Skin Cancer Clinical Trial

Official title:

A Post-market Multi-Center Retrospective-Prospective Study to Assess Long-term Clinical Outcomes of Non-melanoma Skin Cancer Patients Treated With eBx

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05257486
• Other study ID #: CTPR-0019
• Status: Enrolling by invitation
• Start date: March 9, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2022
• Source: Xoft, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Non-melanoma Skin Cancer
• Skin Neoplasms

Intervention

Device:
• Xoft eBx
The Xoft Axxent Electronic Brachytherapy (eBx) System allows for the administration of high dose rate brachytherapy treatments using an electronic source

Locations

Country	Name	City	State
United States	Kenneth A. Miller, MD Dermatology	Campbell	California
United States	Dermatology & Laser Center of San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Xoft, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Recurrence	Absence of local recurrence at = 5-year follow-up by physician assessment at treatment site(s).	Range of 5-10 years post last eBx treatment
Secondary	Skin Toxicities	Occurrence of long-term skin toxicities by physician assessment.	Range of 5-10 years post last eBx treatment