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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
assess the cosmetic outcome of ESSB
efficacy of Electronic Skin Surface Brachytherapy (ESSB)
Secondary outcome measures
reported quality of life
severity of adverse events
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
Find a Location
Who is running the clinical trial?
Lynn Cancer InstituteUNKNOWN
1 Previous Clinical Trials
31 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,584 Total Patients Enrolled
Christopher Barker, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
316 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My skin cancer has come back after treatment.I am taking a drug that affects how my body responds to radiation therapy.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.I have skin cancer in areas often injured like hands, elbows, or shins.I have skin cancer spots close to each other.I have inflammation in the area being studied.My diabetes is not well-managed.I have a genetic condition that increases my risk for skin cancer or sensitivity to radiation.My skin cancer is less than 1 cm in size.My cancer is considered low risk according to AJCC 2010 criteria.I can care for myself but may not be able to do heavy physical work.I can complete health surveys in English.I have a collagen vascular disease like lupus, scleroderma, or rheumatoid arthritis.I have been diagnosed with basal or squamous cell skin cancer.My skin cancer is on a part of my body that isn't flat.
Research Study Groups:
This trial has the following groups:- Group 1: Electronic Skin Surface Brachytherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many Canadian healthcare facilities are currently conducting this research?
"8 different medical institutions are currently taking part in this trial, including the Memorial Sloan Kettering Cancer Center in New york, Memorial Sloan Kettering Nassau (Consent only) located in Uniondale and Boca Raton Regional Hospital. Additionally, there are 5 other various sites that have joined the study."
Answered by AI
Are there opportunities for new participants in this clinical trial?
"While not currently recruiting, the clinical trial's details found on clinicaltrials.gov indicate that this investigation was initially posted in May 2014 and had its last update on April 15th 2022. On the plus-side, there are 2597 other trials actively admitting participants into their studies at present."
Answered by AI
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