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
  Purpose

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 Intervention
Basal Cell Carcinoma
Squamous Cell Carcinoma
Radiation: electronic brachytherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Xoft Electronic Brachytherapy Clinical Protocol For The Primary Treatment Of Non-Melanoma Skin Cancer

Resource links provided by NLM:


Further study details as provided by Xoft, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: July 2009
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
  • 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary basal cell and primary squamous cell carcinomas

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016899

Contacts
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

Locations
United States, Alabama
DCH Cancer Center Recruiting
Tuscaloosa, Alabama, United States, 35401
Contact: Cindy Perkins, RN, PhD    205-343-8331    cperkins@dchsystem.com   
Principal Investigator: Curtis Tucker, MD         
United States, Arizona
Cancer Treatment Services - AZ Recruiting
Casa Grande, Arizona, United States, 85222
Contact: Rebecca Fisher, RN, BS    520-374-9903    rfisher@cancertreatmentservices.com   
Principal Investigator: Ajay Bhatnagar, MD, MBA         
Southwest Oncology Centers Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Mary Grado, RN, MS    480-614-6300    ggrado@aol.com   
Principal Investigator: Gordon Grado, MD         
United States, California
Diablo Valley Oncology and Hematology Medical Group Recruiting
Pleasant Hill, California, United States, 94523
Contact: Gila Fucana, NP    925-677-5041      
Principal Investigator: Sachin Kamath, MD         
United States, Tennessee
Parkridge Medical Center - Sara Cannon Cancer Center Not yet recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Karen Davenport, BSN    423-493-6828    Karen.davenport@hcahealthcare.com   
Principal Investigator: Stephen Golder, MD         
Sponsors and Collaborators
Xoft, Inc.
Investigators
Principal Investigator: Ajay Bhatnagar, MD, MBA Cancer Treatment Services-AZ
  More Information

Publications:
Responsible Party: Xoft, Inc.
ClinicalTrials.gov Identifier: NCT01016899     History of Changes
Other Study ID Numbers: CTPR-0002
Study First Received: November 13, 2009
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Xoft, Inc.:
Electronic
Brachytherapy
Nonmelanoma
cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on August 21, 2014