Electronic Brachytherapy for the Treatment of NMSC

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Xoft, Inc.
Sponsor:
Information provided by (Responsible Party):
Xoft, Inc.
ClinicalTrials.gov Identifier:
NCT01016899
First received: November 13, 2009
Last updated: January 16, 2014
Last verified: January 2014

November 13, 2009
January 16, 2014
July 2009
December 2015   (final data collection date for primary outcome measure)
Local recurrence of NMSC [ Time Frame: at six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01016899 on ClinicalTrials.gov Archive Site
  • Cosmetic outcomes for patients treated for NMSC [ Time Frame: (1) month, three (3) months, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years. ] [ Designated as safety issue: No ]
  • Occurrence of radiation therapy related skin toxicities [ Time Frame: 1, 3, 6 months, and 1, 2, 3, 4, and 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Electronic Brachytherapy for the Treatment of NMSC
Xoft Electronic Brachytherapy Clinical Protocol For The Primary Treatment Of Non-Melanoma Skin Cancer

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Primary basal cell and primary squamous cell carcinomas

  • Basal Cell Carcinoma
  • Squamous 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
  • Electronic Brachytherapy
Non-melanoma skin cancer
Early stage squamous or basal cell carcinoma
Intervention: Radiation: electronic brachytherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
February 2016
December 2015   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact: Michael A Patz, BS, MBA, RAC 603-882-5200 ext 7308 mpatz@icadmed.com
Contact: Heidi M Matthews, BA, CCRA 603-882-5200 ext 7357 hmatthews@icadmed.com
United States
 
NCT01016899
CTPR-0002
Yes
Xoft, Inc.
Xoft, Inc.
Not Provided
Principal Investigator: Ajay Bhatnagar, MD, MBA Cancer Treatment Services-AZ
Xoft, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP