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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01016899
Other study ID # CTPR-0002
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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