Electronic Brachytherapy for the Treatment of NMSC
- Conditions
- Squamous Cell CarcinomaBasal Cell Carcinoma
- Interventions
- Radiation: electronic brachytherapy
- Registration Number
- NCT01016899
- Lead Sponsor
- Xoft, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 187
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-melanoma skin cancer electronic brachytherapy Early stage squamous or basal cell carcinoma
- Primary Outcome Measures
Name Time Method Local recurrence of NMSC at six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years. Local recurrence
- Secondary Outcome Measures
Name Time Method Cosmetic outcomes for patients treated for NMSC (1) month, three (3) months, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years. Cosmetic outcomes
Occurrence of radiation therapy related skin toxicities 1, 3, 6 months, and 1, 2, 3, 4, and 5 years Skin toxicities
Trial Locations
- Locations (5)
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