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

NCT05257486 | Completed Results FDA Device

• 1 other identifier: CTPR-0019
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-melanoma Skin Cancer

Keywords

NMSC

Outcome Measures

Primary Outcomes (1)

• Local Recurrence

  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.

  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.

Secondary Outcomes (1)

• 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.

Study Arms (1)

NMSC Treatment

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

Device: Xoft eBx

Interventions

Xoft eBx DEVICE

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

NMSC Treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The first phase of this study will be to identify patients who completed treatment with eBx at least five years ago prior to study onset and collect history and demographic data, and eligibility data retrospectively from the patient records and on source worksheets.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xoft, Inc.: lead

Study Sites (2)

Kenneth A. Miller, MD Dermatology

Campbell, California, 95032, United States

Location

Dermatology & Laser Center of San Diego

San Diego, California, 91910, United States

Location

Related Publications (1)

• 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.

  PMID: 36970438 RESULT

Related Links

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

Results Point of Contact

• Title: Robert Burnside
• Organization: Xoft, Inc.

rob.burnside@elekta.com

14084931533

Study Officials

• Stephen Doggett, MD

  Mission Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 25, 2022
• Study Start: March 9, 2022
• Primary Completion: July 18, 2022
• Study Completion: October 13, 2022
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)