Electronic Brachytherapy for the Treatment of NMSC

Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01016899
• Other study ID #: CTPR-0002
• Status: Completed
• Start date: August 2009
• Est. completion date: August 2013

Study information

• Verified date: December 2022
• Source: Xoft, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Squamous Cell Carcinoma

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Xoft, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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