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

NCT ID: NCT05257486

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 183 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2022-10-13

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.

Conditions

Non-melanoma Skin Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

NMSC Treatment

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

Xoft eBx

Intervention Type: DEVICE

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

Interventions

Xoft eBx

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xoft, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Doggett, MD

Role: PRINCIPAL_INVESTIGATOR

Mission Health

Locations

Kenneth A. Miller, MD Dermatology

Campbell, California, United States

Dermatology & Laser Center of San Diego

San Diego, California, United States

Countries

United States

References

Doggett SW, Willoughby M, Miller KA, Mafong E. Long-term clinical outcomes of non-melanoma skin cancer patients treated with electronic brachytherapy. J Contemp Brachytherapy. 2023 Feb;15(1):9-14. doi: 10.5114/jcb.2023.125580. Epub 2023 Feb 28.

Reference Type: RESULT

PMID: 36970438 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://doi.org/10.5114/jcb.2023.125580

Long-term clinical outcomes of non-melanoma skin cancer patients treated with electronic brachytherapy

Other Identifiers

CTPR-0019

Identifier Type: -

Identifier Source: org_study_id