Comparison of eBX and Mohs Surgery for Treatment of Early-stage Non-melanoma Skin Cancer a Matched Pair Cohort Study.

Xoft

Status: Completed

Conditions: Nonmelanoma Skin Cancer

Treatments: Procedure: Electronic Brachytherapy

Study type: Observational

Funder types: Industry

Identifiers

NCT03024866

CTPR-0014

Details and patient eligibility

About

This is a retrospective-prospective study design. Patients who completed treatment approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be identified and any existing data in the patient's record will be collected in addition to conducting office visits for long-term follow-up.

Full description

This is a retrospective-prospective study design. Patients who completed treatment approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be identified and any existing data in the patient's record will be collected in addition to conducting office visits for long-term follow-up. The study will include 2 parts:

1. Retrospective chart review: Collect data from patient records who completed treatment a minimum of 2 years prior to study onset and determine the feasibility of doing a matched pair cohort study comparison of eBx versus Mohs surgery. The history, demographic and treatment data will be retrospectively collected from up to 320 subjects previously treated with eBx for the treatment of NMSC and up to 320 subjects previously treated with Mohs surgery for the treatment of NMSC.
2. Prospective Follow-up: Patients will return for long-term follow-up visits for the investigators to assess the lesion site, document absence of recurrence/ absence of recurrence, toxicities, and collect patient reported outcomes.

Enrollment: 369 patients

Sex: All

Ages: 41+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System or Mohs surgery;

2. Provides informed Consent;

3. Greater than 40 years of age;

4. Pathological diagnosis confirmed to be squamous cell or basal cell carcinoma prior to treatment;

5. Cancer Staging included in this study:

   • Stage 0: Tis, N0, M0
   • Stage 1: T1, N0, M0
   • Stage 2: T2, N0, M0 and ≤ 4cm in diameter

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

Trial design

369 participants in 2 patient groups

Electronic Brachytherapy

Description:

Procedure/Surgery: Electronic Brachytherapy: Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System. High-dose-rate electronic brachytherapy (EBT) provides a non-surgical treatment option for non-melanoma skin cancer (NMSC).

Treatment:

Procedure: Electronic Brachytherapy

Mohs Surgery

Description:

Previously completed treatment for non-melanoma skin cancer using Mohs Surgery: Uniquely orients, maps, and processes removed tissue, permitting the microscopic evaluation of virtually 100% of the specimen margins. The completeness of this margin control permits the accurate identification and removal of all tumor extensions under the microscope. Tissues in Mohs surgery are processed as modified frozen sections which allow the accurate and rapid interpretation of most skin cancers.

Treatment:

Procedure: Electronic Brachytherapy