Electronic Brachytherapy for Skin Cancer

No longer recruiting at 8 trial locations

Overseen By Michael Zelefsky, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Radiosensitizers, Radioprotectors

Disqualifiers: Recurrent BCC/SCC, Collagen vascular disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 2-3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new treatment for early-stage skin cancer, specifically basal or squamous cell carcinoma, using the Esteya Electronic Skin Surface Brachytherapy System. The researchers aim to assess the device's effectiveness, safety, and impact on appearance and quality of life. Participants will receive treatment over several outpatient visits and will be monitored for five years. This trial is suitable for individuals aged 60 or older with a new diagnosis of early-stage basal or squamous cell skin cancer that hasn't been treated. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance future skin cancer treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking a drug that affects how your body responds to radiation, you may not be eligible to participate.

What prior data suggests that this device is safe for treating skin cancer?

Research has shown that electronic skin surface brachytherapy, a type of radiation treatment, is generally safe and effective for treating non-melanoma skin cancers, such as basal and squamous cell carcinoma. Studies indicate that this treatment cures more than 95% of these skin cancers.

Most patients tolerate this treatment well. Reports highlight excellent long-term cancer control, with only a small chance of recurrence. Specifically, about 2.5% of patients experienced a return of cancer within five years. Additionally, most patients achieve good cosmetic results, meaning their skin appears normal after treatment.

Overall, electronic brachytherapy is considered a safe option with a strong track record for treating non-melanoma skin cancers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for skin cancer, such as surgical excision or radiation therapy, Electronic Skin Surface Brachytherapy offers a unique approach by delivering radiation directly to the skin's surface using electronic means. This method allows for precise targeting of the tumor, potentially reducing damage to surrounding healthy tissue. Additionally, it requires fewer treatment sessions over a shorter period, making it more convenient for patients. Researchers are excited about this treatment because it could improve patient quality of life and provide effective cancer control with minimal side effects.

What evidence suggests that this device is effective for skin cancer?

Studies have shown that electronic skin surface brachytherapy (ESSB), the treatment tested in this trial, effectively treats non-melanoma skin cancers like basal and squamous cell carcinoma. Research indicates a high success rate of 98.9%, with cancer staying away in almost all cases. Clinical studies report cure rates comparable to or better than traditional treatments. After more than five years, only 2% of treated areas showed cancer recurrence. Most patients found the cosmetic results excellent or good, with the treated area appearing healthy and normal after the procedure. Overall, ESSB presents a promising option for early-stage skin cancer treatment. ^{1 2 3 4 5}

Who Is on the Research Team?

Christopher Barker, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for men and women over 60 with a life expectancy of at least 5 years, diagnosed with early stage basal or squamous cell carcinoma. Participants must be able to speak English, provide consent, have certain low-risk cancer features, and an ECOG performance status of 0-3. Those with previously treated cancers, diabetes that's poorly controlled, genetic disorders affecting skin or radiation response are excluded.

Inclusion Criteria

Ability to provide informed consent

I am 60 or older and expected to live 5 more years or longer.

My cancer is in the early stage and has not spread to lymph nodes or other parts.

Exclusion Criteria

I have skin cancer in the same area where I previously had radiation.

My skin cancer is near or on a burn scar.

I have skin cancer in an area with poor blood or lymph flow.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo electronic skin surface brachytherapy over six outpatient visits using the Nucletron's Esteya system

2-3 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety, cosmetic results, and quality of life, with follow-up lasting up to 5 years

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Electronic Skin Surface Brachytherapy

Trial Overview

The study tests the effectiveness of a new device called Esteya Electronic Skin Surface Brachytherapy System on treating early-stage skin cancer. It aims to evaluate the safety and cosmetic outcomes of this treatment as well as its impact on patients' quality of life.

How Is the Trial Designed?

Group I: Electronic Skin Surface Brachytherapy Experimental Treatment 2 Interventions

The patient will undergo quality of life assessment and skin imaging (ultrasonography and reflectance confocal microscopy). Brachytherapy will be performed over six outpatient visits over 2-3 weeks, on non-consecutive days. Patients will then be followed for 5 years. Reflectance confocal microscopy is optional for the participating sites.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lynn Cancer Institute

Collaborator

Trials

2

Recruited

70+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10034722/

Long-term clinical outcomes of non-melanoma skin cancer ...

Electronic brachytherapy for the treatment of non-melanoma skin cancer is safe and effective, showing excellent long-term 98.9% of local control, with a median ...

2.

dermatologyseattle.com

dermatologyseattle.com/electronic-brachytherapy-revolutionizing-skin-cancer-treatment-today/

Electronic Brachytherapy Revolutionizing Skin Cancer ...

High Cure Rates: Clinical studies consistently show excellent outcomes, with cure rates comparable to or better than traditional methods.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8565634/

Electronic brachytherapy for treatment of non-melanoma ...

[48] found that with superficial radiation, the relapse-free survival declines from 95.8% at 1 year to 80.4% at 10 years, illustrating the need for longer ...

4.

providers.lablue.com

providers.lablue.com/-/media/Files/Providers/Blue%20Advantage%20Resources/2024-07%20Electronic%20Brachytherapy%20Nonmelanoma%20Skin%20Cancer%20MNG-024%20pdf.pdf

Electronic Brachytherapy for Nonmelanoma Skin Cancer

Electronic brachytherapy is a form of radiotherapy designed to deliver high-dose rate radiation to treat nonmelanoma skin cancer (NMSC). This technique focuses ...

5.

member.myhealthtoolkitks.com

member.myhealthtoolkitks.com/web/public/brands/medicalpolicyhb/external-policies/electronic-brachytherapy-for-nonmelanoma-skin-cancer/

Electronic Brachytherapy for Nonmelanoma Skin Cancer

After a median follow-up of 66 months, there were recurrences in 2% (4/236) of treated lesions. Cosmetic outcome was judged to be excellent or good in 88% (208/ ...