Squamous Cell Carcinoma Clinical Trial
Official title:
Xoft Electronic Brachytherapy Clinical Protocol For The Primary Treatment Of Non-Melanoma Skin Cancer
NCT number | NCT01016899 |
Other study ID # | CTPR-0002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2009 |
Est. completion date | August 2013 |
Verified date | December 2022 |
Source | Xoft, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 187 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - Patient has signed the informed consent form - 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: - T2 > 4 cm and T3 and T4 - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Cancer Treatment Services - AZ | Casa Grande | Arizona |
United States | Parkridge Medical Center - Sara Cannon Cancer Center | Chattanooga | Tennessee |
United States | Diablo Valley Oncology and Hematology Medical Group | Pleasant Hill | California |
United States | Southwest Oncology Centers | Scottsdale | Arizona |
United States | DCH Cancer Center | Tuscaloosa | Alabama |
Lead Sponsor | Collaborator |
---|---|
Xoft, Inc. |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Local recurrence of NMSC | Local recurrence | at six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years. | |
Secondary | Cosmetic outcomes for patients treated for NMSC | Cosmetic outcomes | (1) month, three (3) months, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years. | |
Secondary | Occurrence of radiation therapy related skin toxicities | Skin toxicities | 1, 3, 6 months, and 1, 2, 3, 4, and 5 years |
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