NCT03693937

A Retrospective Evaluation of Superficial Radiation Therapy (SRT) and Non-Melanoma Skin Cancer (NMSC)

Completed Results posted Last updated 5 July 2019

What this trial tests

trial testing SRT-100 in Non-melanoma Skin Cancer in 776 participants. Completed in 16 March 2019.

Timeline

15 November 2018

Primary endpoint
16 March 2019

16 March 2019

Quick facts

Lead sponsor	Sensus Healthcare
Status	Completed
Study type	OBSERVATIONAL
Enrollment	776
Start date	15 November 2018
Primary completion	16 March 2019
Estimated completion	16 March 2019
Sites	1 location across United States

Drugs / interventions tested

• SRT-100

Conditions studied

• Non-melanoma Skin Cancer — all drugs for Non-melanoma Skin Cancer →

Sponsor

Sensus Healthcare

Who can join

18 and older, any sex, with Non-melanoma Skin Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cure Rate Primary · 5 years

NMSC cure rate will be calculated as the percentage of lesions that attained complete cure following SRT-100 treatment completion.

Group	Value	95% CI
Non-Melanoma Skin Cancers (NMSCs)	751

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Non-Melanoma Skin Cancers (NMSCs)

Serious: 0/776 (0%)

Deaths: 0/776

Other adverse events (1 terms — click to expand)

Reaction	System	Non-Melanoma Skin Cancers …
Radiation Dermatitis	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT03693937 adverse events section.

Sponsor's own description

Non-Melanoma Skin Cancer (NMSC) is the most commonly occurring type of skin cancer, and predominantly comprises (98%) Basal Cell Carcinomas (BCC) and Squamous Cell Carcinomas (SCC). About 3.3 million people in the United States (U.S.) are diagnosed with NMSC annually, equating about 5.4 million BCCs and SCCs. Low-dose Superficial Radiation Therapy (SRT) effectively destroys BCC and SCC without any invasive cutting, bleeding or stitching. There is no need for anesthesia, no risk of infection or scarring and no need for reconstructive plastic surgery. Healing time is quick with minimal to no post-treatment downtime or lifestyle restrictions. It is therefore both a viable and highly desirable alternative to invasive, painful and higher-risk surgical procedures. This study will utilize retrospective chart analysis to evaluate the outcomes of SRT-100™ therapy on NMSC lesions over a long-term post-treatment period.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.