Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
187 participants
OBSERVATIONAL
2009-08-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Non-melanoma skin cancer
Early stage squamous or basal cell carcinoma
electronic brachytherapy
Post market observational study recording data form patients with skin cancer treated with electronic brachytherapy. Treatment is standard of care, and can vary in dose and fractionation schedule from patient to patient depending on radiation oncologist's judgement for best treatment for the patient.
Interventions
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electronic brachytherapy
Post market observational study recording data form patients with skin cancer treated with electronic brachytherapy. Treatment is standard of care, and can vary in dose and fractionation schedule from patient to patient depending on radiation oncologist's judgement for best treatment for the patient.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pathological diagnosis confirmed of squamous cell or basal cell carcinoma
* Histopathological Grade: G1 (well differentiated), G2 (moderately differentiated), or Gx (Not assessed in report)
* Clinical Staging Tis, T1, or T2 (Must be ≤ 4 cm in diameter)
* One lesion is treated, or more than 1 lesion is treated with a minimum of a 5 mm gap between the edges of the lesion margins.
Exclusion Criteria
* American Joint Committee Staging for NMSC Stages III and IV
* Histopathologic Grade 3 (poorly differentiated) or higher grade
* Target area is adjacent to a burn scar
* Target area is on the lip
* Patient \< 50 years of age
* Any prior definitive surgical resection of the cancer
* Perineural invasion
* Lesion depth \> 5mm on clinical assessment or as assessed by ultrasound or CT.
* Patient is pregnant (pregnancy test required if standard of care).
* Target area is prone to trauma.
* Target area with compromised lymphatic or vascular drainage.
* Participation in another investigational device or drug study concurrently.
* Patient has undergone prior radiation therapy to this specific anatomic location.
* Patient is receiving pharmacologic agent(s) at or around the time of the Radiation therapy that is/are known to produce skin reactions that will influence cosmesis grading during study.
* Patient is receiving chemotherapeutic agent(s) Six (6) weeks before or six (6) weeks after radiation therapy.
* Life expectancy less than five (5) years.
50 Years
ALL
No
Sponsors
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Xoft, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ajay Bhatnagar, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Cancer Treatment Services-AZ
Locations
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DCH Cancer Center
Tuscaloosa, Alabama, United States
Cancer Treatment Services - AZ
Casa Grande, Arizona, United States
Southwest Oncology Centers
Scottsdale, Arizona, United States
Diablo Valley Oncology and Hematology Medical Group
Pleasant Hill, California, United States
Parkridge Medical Center - Sara Cannon Cancer Center
Chattanooga, Tennessee, United States
Countries
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References
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Bhatnagar A, Loper A. The initial experience of electronic brachytherapy for the treatment of non-melanoma skin cancer. Radiat Oncol. 2010 Sep 28;5:87. doi: 10.1186/1748-717X-5-87.
Other Identifiers
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CTPR-0002
Identifier Type: -
Identifier Source: org_study_id