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Brachytherapy

Electronic Brachytherapy for Skin Cancer

N/A

Waitlist Available

Led By Christopher Barker, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men or women ≥ 60 years old with estimated life expectancy of ≥ 5 years

Clinical stage T1N0M0 (by AJCC 2010 criteria)

Must not have

BCC/SCC in region adjacent to or overlapping with region of prior radiotherapy

BCC/SCC adjacent to or overlapping with burn or scar

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new device for treating skin cancer with electronic brachytherapy. The device's effectiveness, safety, and cosmetic results will be studied, as well as its effects on quality of life.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, brachytherapy can generally cause skin redness, irritation or dryness in the treated area. There may also be risks associated with radiation exposure such as changes in skin texture or color.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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My skin cancer is less than 1 cm in size.

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I can care for myself but may not be able to do heavy physical work.

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I have been diagnosed with basal or squamous cell skin cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My skin cancer is near or on a burn scar.

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

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My skin cancer has come back after treatment.

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I am taking a drug that affects how my body responds to radiation therapy.

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I have skin cancer in areas often injured like hands, elbows, or shins.

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I have skin cancer spots close to each other.

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I have inflammation in the area being studied.

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My diabetes is not well-managed.

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I have a genetic condition that increases my risk for skin cancer or sensitivity to radiation.

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I have a collagen vascular disease like lupus, scleroderma, or rheumatoid arthritis.

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My skin cancer is on a part of my body that isn't flat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

assess the cosmetic outcome of ESSB

efficacy of Electronic Skin Surface Brachytherapy (ESSB)

Secondary study objectives

reported quality of life

severity of adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Electronic Skin Surface BrachytherapyExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Quality of life assessment

2020

N/A

~570

0 / 17Eligibility criteria met