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| Sponsor: | Xoft, Inc. |
|---|---|
| Information provided by: | Xoft, Inc. |
| ClinicalTrials.gov Identifier: | NCT01016899 |
Purpose
The objective of this study is to record recurrence in patients treated for nonmelanoma (basal cell and squamous cell carcinomas) skin cancer using the Xoft Axxent Electronic Brachytherapy System. Additional objectives include evaluate the appearance of the treated area in patients treated for nonmelanoma skin cancer using the Xoft Axxent Electronic Brachytherapy System and record the occurrence of radiation therapy related skin changes in patients treated for nonmelanoma skin cancer.
| Condition | Intervention |
|---|---|
|
Basal Cell Carcinoma Squamous Cell Carcinoma |
Radiation: electronic brachytherapy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Xoft Electronic Brachytherapy Clinical Protocol For The Primary Treatment Of Non-Melanoma Skin Cancer |
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Non-melanoma skin cancer
Early stage squamous or basal cell carcinoma
|
Radiation: 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 Names:
|
The objective of this study is to record local recurrence in patients treated for nonmelanoma (basal cell and squamous cell carcinomas) skin cancer using the Xoft Axxent Electronic Brachytherapy System. Additional objectives include evaluate the cosmetic outcomes in patients treated for nonmelanoma skin cancer using the Xoft Axxent Electronic Brachytherapy System and record the occurrence of radiation therapy related skin toxicities in patients treated for nonmelanoma skin cancer using the Xoft Axxent Electronic Brachytherapy System.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Primary basal cell and primary squamous cell carcinomas
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kelly W Elliott, RN, MS | 408-419-2428 | Kelliott@xoftinc.com |
| Contact: Patricia R McCarthy, RN, BA | 314-409-2899 | Pmccarthy@xoftinc.com |
| United States, Alabama | |
| DCH Cancer Center | Recruiting |
| Tuscaloosa, Alabama, United States, 35401 | |
| Contact: Cindy Perkins, RN, PhD 205-343-8331 cperkins@dchsystem.com | |
| Principal Investigator: Curtis Tucker, MD | |
| United States, Arizona | |
| Cancer Treatment Services - AZ | Recruiting |
| Casa Grande, Arizona, United States, 85222 | |
| Contact: Rebecca Fisher, RN, BS 520-374-9903 rfisher@cancertreatmentservices.com | |
| Principal Investigator: Ajay Bhatnagar, MD, MBA | |
| Southwest Oncology Centers | Recruiting |
| Scottsdale, Arizona, United States, 85251 | |
| Contact: Mary Grado, RN, MS 480-614-6300 ggrado@aol.com | |
| Principal Investigator: Gordon Grado, MD | |
| United States, California | |
| Diablo Valley Oncology and Hematology Medical Group | Recruiting |
| Pleasant Hill, California, United States, 94523 | |
| Contact: Gila Fucana, NP 925-677-5041 | |
| Principal Investigator: Sachin Kamath, MD | |
| United States, New York | |
| Beth Israel Medical Center | Recruiting |
| New York City, New York, United States, 10003 | |
| Contact: Sherly Jacob-Perez, BS 212-844-8292 sjacob@chpnet.org | |
| Principal Investigator: Kenneth Hu, MD | |
| United States, Tennessee | |
| Parkridge Medical Center - Sara Cannon Cancer Center | Not yet recruiting |
| Chattanooga, Tennessee, United States, 37404 | |
| Contact: Karen Davenport, BSN 423-493-6828 Karen.davenport@hcahealthcare.com | |
| Principal Investigator: Stephen Golder, MD | |
| Principal Investigator: | Ajay Bhatnagar, MD, MBA | Cancer Treatment Services-AZ |
More Information
| Responsible Party: | Kelly W. Elliott, RN, MS, Xoft, Inc. |
| ClinicalTrials.gov Identifier: | NCT01016899 History of Changes |
| Other Study ID Numbers: | CTPR-0002 |
| Study First Received: | November 13, 2009 |
| Last Updated: | January 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Electronic Brachytherapy Nonmelanoma cancer |
|
Carcinoma Carcinoma, Basal Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Basal Cell Neoplasms, Squamous Cell |