Clinical trial NCT01016899: Electronic Brachytherapy for the Treatment of NMSC
Official title: Xoft Electronic Brachytherapy Clinical Protocol For The Primary Treatment Of Non-Melanoma Skin Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Cell Carcinoma
Squamous Cell Carcinoma
Keywords: Electronic
Brachytherapy
Nonmelanoma
cancer
Lead sponsor: Xoft, Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-20
Enrollment: 187
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary basal cell and primary squamous cell carcinomas

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Local recurrence of NMSC
timeFrame: at six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years.
Secondary outcomes:
measure: Cosmetic outcomes for patients treated for NMSC
timeFrame: (1) month, three (3) months, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years.
measure: Occurrence of radiation therapy related skin toxicities
timeFrame: 1, 3, 6 months, and 1, 2, 3, 4, and 5 years
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: DCH Cancer Center
state: Alabama
city: Casa Grande
country: United States
facility: Cancer Treatment Services - AZ
state: Arizona
city: Scottsdale
country: United States
facility: Southwest Oncology Centers
state: Arizona
city: Pleasant Hill
country: United States
facility: Diablo Valley Oncology and Hematology Medical Group
state: California
city: Chattanooga
country: United States
facility: Parkridge Medical Center - Sara Cannon Cancer Center
state: Tennessee
Study officials:
affiliation: Cancer Treatment Services-AZ
name: Ajay Bhatnagar, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.