Electronic Brachytherapy for the Treatment of NMSC

Completed

Conditions studied: Basal Cell Carcinoma, Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT01016899

Run by

Xoft, Inc.

People needed

187

Starts

2009-08-01

Expected to finish

2013-08-01

Last updated by the study team

2022-12-13

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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