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


N/A
50 Years
N/A
Open (Enrolling)
Both
Basal Cell Carcinoma, Squamous Cell Carcinoma

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Local recurrence of NMSC

Outcome Time Frame:

at six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years.

Safety Issue:

No

Principal Investigator

Ajay Bhatnagar, MD, MBA

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Treatment Services-AZ

Authority:

United States: Institutional Review Board

Study ID:

CTPR-0002

NCT ID:

NCT01016899

Start Date:

July 2009

Completion Date:

February 2016

Related Keywords:

  • Basal Cell Carcinoma
  • Squamous Cell Carcinoma
  • Electronic
  • Brachytherapy
  • Nonmelanoma
  • cancer
  • Carcinoma
  • Carcinoma, Basal Cell
  • Carcinoma, Squamous Cell

Name

Location

Beth Israel Medical CenterNew York, New York  10003
DCH Cancer CenterTuscaloosa, Alabama  35401
Cancer Treatment Services - AZCasa Grande, Arizona  85222
Southwest Oncology CentersScottsdale, Arizona  85251
Diablo Valley Oncology and Hematology Medical GroupPleasant Hill, California  94523
Parkridge Medical Center - Sara Cannon Cancer CenterChattanooga, Tennessee  37404