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Radiation Therapy

Radiotherapy for Keloids

Phase < 1

Recruiting

Research Sponsored by Albert Einstein College of Medicine

Eligibility Criteria Checklist

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

Must have

Clinically diagnosed keloid

Surgical excision of keloid is either contraindicated or patient has declined treatment with surgical excision

Must not have

Prior RT to the area of interest that would result in overlap of radiation therapy fields

Females of childbearing age without a negative serum pregnancy test prior to initiation of RT or unwilling to use contraception prior to and during the radiation course

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if radiation therapy is a safe and effective treatment for keloids that cannot be removed by surgery. The study will measure if the keloids shrink or stop growing, if symptoms improve, and if quality of life gets better.

Who is the study for?

This trial is for adults with clinically diagnosed keloids where surgery isn't an option or has been declined. It's open to those who have had keloids return after resection, as long as the current one can't be removed or they choose not to have it surgically treated. Women must test negative for pregnancy and agree to use contraception.

What is being tested?

The study is testing the safety and effectiveness of radiation therapy on keloids that haven’t been removed by surgery. The main goal is to check for any side effects within 10 weeks, while also looking at whether the keloid stops growing, shrinks, feels better symptomatically, and improves life quality.

What are the potential side effects?

Potential side effects from radiation therapy may include skin irritation, changes in skin coloration, fatigue, localized hair loss around the treatment area, and a slight risk of secondary cancers due to exposure.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a keloid.

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Surgery for my keloid is not an option or I have chosen not to have it.

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I am 18 years old or older.

Exclusion Criteria

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

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I have had radiation therapy before in the same area where it's now planned.

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I am of childbearing age and will take a pregnancy test before radiation or use birth control during treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Toxicity of the radiation

Secondary study objectives

Size of keloids

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: Radiation therapy groupExperimental Treatment1 Intervention

Single-institution pilot study to evaluate the safety and efficacy of radiation therapy (RT) for the treatment of unresected keloids. The primary endpoint will be toxicity within 10 weeks of follow-up. Secondary endpoints will include cessation of growth or shrinkage of keloids, symptomatic response, and impact on quality of life.

0 / 5Eligibility criteria met