N/A
N=776
A Retrospective Evaluation of Superficial Radiation Therapy (SRT) and Non-Melanoma Skin Cancer (NMSC)
Non-melanoma Skin Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03693937 ↗Enrolled (actual)
776
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Cure Rate — 751 lesions
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- SRT-100 (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sensus Healthcare
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cure Rate |
751 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Treatment with SRT-100™.
- Treatment date of December 31, 2015 or earlier.
- Non-Melanoma Skin Cancer (NMSC) pathological diagnosis of confirmed squamous cell carcinoma (SCC) or basal cell carcinoma (BCC).
- Histopathological Grade: G1 (well differentiated); G2 (moderately differentiated) or Gx (not assessed).
- One lesion is treated, or more than one lesion is treated with a minimum of a 5 mm gap between the edges of the lesion margins.
- Required retrospective data is existing and sufficient.
Exclusion Criteria
- Lesions of etiology other than non-melanoma skin cancer (NMSC)
Data sourced from ClinicalTrials.gov (NCT03693937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.