Xoft Electronic Brachytherapy Clinical Protocol For The Primary Treatment Of Non-Melanoma Skin Cancer

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.