Electronic Brachytherapy for the Treatment of NMSC

NCT01016899 | Completed DMC

• 1 other identifier: CTPR-0002
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 5

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.

Conditions

Basal Cell Carcinoma; Squamous Cell Carcinoma

Keywords

Electronic; Brachytherapy; Nonmelanoma; cancer

Outcome Measures

Primary Outcomes (1)

• Local recurrence of NMSC

  Local recurrence

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

Secondary Outcomes (2)

• Cosmetic outcomes for patients treated for NMSC

  (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

  1, 3, 6 months, and 1, 2, 3, 4, and 5 years

Study Arms (1)

Non-melanoma skin cancer

Early stage squamous or basal cell carcinoma

Radiation: electronic brachytherapy

Interventions

electronic brachytherapy RADIATION

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.

Also known as: Xoft Axxent System

Non-melanoma skin cancer

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary basal cell and primary squamous cell carcinomas

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xoft, Inc.: lead

Study Sites (5)

DCH Cancer Center

Tuscaloosa, Alabama, 35401, United States

Location

Cancer Treatment Services - AZ

Casa Grande, Arizona, 85222, United States

Location

Southwest Oncology Centers

Scottsdale, Arizona, 85251, United States

Location

Diablo Valley Oncology and Hematology Medical Group

Pleasant Hill, California, 94523, United States

Location

Parkridge Medical Center - Sara Cannon Cancer Center

Chattanooga, Tennessee, 37404, United States

Location

Related Publications (1)

• 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. doi: 10.1186/1748-717X-5-87.

  PMID: 20875139 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell; Neoplasms, Squamous Cell

Study Officials

• Ajay Bhatnagar, MD, MBA

  Cancer Treatment Services-AZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: November 20, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

US (5)