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Electronic Brachytherapy for the Treatment of NMSC

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ClinicalTrials.gov Identifier: NCT01016899
Recruitment Status : Active, not recruiting
First Posted : November 20, 2009
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Xoft, Inc.

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
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 Type : Observational
Estimated 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 : July 2009
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Group/Cohort 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 Name: Xoft Axxent System




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. Occurrence of radiation therapy related skin toxicities [ Time Frame: 1, 3, 6 months, and 1, 2, 3, 4, and 5 years ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016899


Locations
United States, Alabama
DCH Cancer Center
Tuscaloosa, Alabama, United States, 35401
United States, Arizona
Cancer Treatment Services - AZ
Casa Grande, Arizona, United States, 85222
Southwest Oncology Centers
Scottsdale, Arizona, United States, 85251
United States, California
Diablo Valley Oncology and Hematology Medical Group
Pleasant Hill, California, United States, 94523
United States, Tennessee
Parkridge Medical Center - Sara Cannon Cancer Center
Chattanooga, Tennessee, United States, 37404
Sponsors and Collaborators
Xoft, Inc.
Investigators
Principal Investigator: Ajay Bhatnagar, MD, MBA Cancer Treatment Services-AZ

Publications:
Responsible Party: Xoft, Inc.
ClinicalTrials.gov Identifier: NCT01016899     History of Changes
Other Study ID Numbers: CTPR-0002
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

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

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