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Basal Cell Carcinoma | Electronic Brachytherapy for the Treatment of NMSC

Basal Cell Carcinoma research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Basal Cell Carcinoma

Squamous Cell Carcinoma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Radiation:electronic brachytherapyPost 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Non-melanoma skin cancerEarly stage squamous or basal cell carcinoma

Study Status

Unknown status

Start Date: July 2009

Completed Date: February 2018

Phase:

Type: Observational

Design:

Primary Outcome: Local recurrence of NMSC

Secondary Outcome: Cosmetic outcomes for patients treated for NMSC

Study sponsors, principal investigator, and references

Principal Investigator: Ajay Bhatnagar, MD, MBA

Lead Sponsor: Xoft, Inc.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01016899

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.

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