Electronic Brachytherapy for the Treatment of NMSC

Sponsor

Xoft, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01016899

Collaborator

(none)

100

Enrollment

Locations

103.1

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Basal Cell Carcinoma Squamous Cell Carcinoma	Radiation: electronic brachytherapy

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2009

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Non-melanoma skin cancer Early stage squamous or basal cell carcinoma	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. Other Names: Xoft Axxent System

Arm

Intervention/Treatment

Non-melanoma skin cancer

Early stage squamous or basal cell carcinoma

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.

Other Names:

Xoft Axxent System

Outcome Measures

Primary Outcome Measures

Local recurrence of NMSC [at six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years.]

Secondary Outcome Measures

Cosmetic outcomes for patients treated for NMSC [(1) month, three (3) months, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years.]
Occurrence of radiation therapy related skin toxicities [1, 3, 6 months, and 1, 2, 3, 4, and 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DCH Cancer Center	Tuscaloosa	Alabama	United States	35401
2	Cancer Treatment Services - AZ	Casa Grande	Arizona	United States	85222
3	Southwest Oncology Centers	Scottsdale	Arizona	United States	85251
4	Diablo Valley Oncology and Hematology Medical Group	Pleasant Hill	California	United States	94523
5	Parkridge Medical Center - Sara Cannon Cancer Center	Chattanooga	Tennessee	United States	37404