Electronic Brachytherapy for the Treatment of NMSC

December 9, 2022 updated by: Xoft, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

187

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35401
        • DCH Cancer Center
    • Arizona
      • Casa Grande, Arizona, United States, 85222
        • Cancer Treatment Services - AZ
      • Scottsdale, Arizona, United States, 85251
        • Southwest Oncology Centers
    • California
      • Pleasant Hill, California, United States, 94523
        • Diablo Valley Oncology and Hematology Medical Group
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Parkridge Medical Center - Sara Cannon Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary basal cell and primary squamous cell carcinomas

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • Xoft Axxent System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Local recurrence
at six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Cosmetic outcomes
(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
Time Frame: 1, 3, 6 months, and 1, 2, 3, 4, and 5 years
Skin toxicities
1, 3, 6 months, and 1, 2, 3, 4, and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xoft, Inc.

Investigators

  • Principal Investigator: Ajay Bhatnagar, MD, MBA, Cancer Treatment Services-AZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

November 13, 2009

First Submitted That Met QC Criteria

November 19, 2009

First Posted (Estimate)

November 20, 2009

Study Record Updates

Last Update Posted (Actual)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 9, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTPR-0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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