A Retrospective Evaluation of Superficial Radiation Therapy (SRT) and Non-Melanoma Skin Cancer (NMSC)
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|ClinicalTrials.gov Identifier: NCT03693937|
Recruitment Status : Completed
First Posted : October 3, 2018
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
|Condition or disease||Intervention/treatment|
|Non-melanoma Skin Cancer||Radiation: SRT-100|
Non-Melanoma Skin Cancer (NMSC) is the most commonly occurring type of skin cancer and accounts for about one-third of all cancers. NMSCs predominantly (98%) include Basal Cell Carcinomas (BCC) and Squamous Cell Carcinomas (SCC). Basal cell carcinomas (BCC) are abnormal, uncontrolled growths or lesions that arise in the skin's basal cells that line the deepest layer of the epidermis, occurring most commonly on sun-exposed areas of the face, head and neck. They are slow-growing cancers that rarely metastasize. Delayed or ineffective treatment of BCCs can lead to disfigurement of the lesion and recurrence. Squamous cell carcinomas (SCC) are uncontrolled growths of abnormal cells arising from the squamous cells in the epidermis producing keratin, also typically developing on sun-exposed and damaged body areas such as the face, ears, neck, lips, back of the hands, arms and legs. SCCs may be slow or rapidly growing with significant tenderness and pain and may become disfiguring and fatal if left untreated and allowed to grow.
About 3.3 million people in the United States (U.S.) are diagnosed with NMSC annually, equating about 5.4 million BCCs and SCCs. Diagnosis and treatment of NMSC in the U.S. increased by 77% between 1994 and 2014. The incidence of BCC is about 4 times that of SCC. An estimated 4.3 million cases of BCC are diagnosed annually in the U.S. resulting in over 3,000 deaths. Over 1 million cases of SCC are diagnosed in the U.S. annually, resulting in over 15,000 deaths. SCC has a 4% annual incidence of metastasis. About 90% of NMSC is associated with repeated and unprotected skin exposure to ultraviolet (UV) rays
Treatment options for NMSC include surgery, cryotherapy, curettage and electrodesiccation, radiation therapy including superficial radiation therapy (SRT), photodynamic therapy, various forms of brachytherapy, and chemotherapeutic agents.
Low-dose 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.
|Study Type :||Observational|
|Actual Enrollment :||776 participants|
|Official Title:||A Retrospective Registry Study to Evaluate the Long-Term Efficacy and Safety of Superficial Radiation Therapy (SRT) in Individuals With Non-Melanoma Skin Cancer (NMSC) .|
|Actual Study Start Date :||November 15, 2018|
|Actual Primary Completion Date :||March 16, 2019|
|Actual Study Completion Date :||March 16, 2019|
- Radiation: SRT-100
The SRT-100™ is a simple painless non-invasive in-office procedure that is approved by the U.S. Food and Drug Administration (U.S. FDA) to treat keloids caused by surgery or injury by delivering a precise, calibrated dose of Superficial Radiation Therapy (SRT) that only goes skin deep.
- Cure Rate [ Time Frame: 5 years ]NMSC cure rate will be calculated as the percentage of lesions that attained complete cure following SRT-100 treatment completion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693937
|United States, Florida|
|Dermatology and Dermatological Surgery|
|Boynton Beach, Florida, United States, 33437|
|Principal Investigator:||William Roth, M.D.|