RecruitingNot ApplicableNCT04722263
Radiotherapy for Keloids
Primary Radiotherapy for the Treatment of Keloids: A Pilot Study
Sponsor
Montefiore Medical Center
Enrollment
15 participants
Start Date
Dec 1, 2020
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Clinically diagnosed keloid
- Surgical excision of keloid is either contraindicated or patient has declined treatment with surgical excision (Note: patients with keloids that recurred after previous resection are eligible, as long as the current keloid is either unresectable or patient has declined resection)
- Age ≥ 18
- Study specific informed consent provided
Exclusion Criteria4
- Prior RT to the area of interest that would result in overlap of radiation therapy fields
- Females of child bearing age without a negative serum pregnancy test prior to initiation of RT or unwilling to use contraception prior to and during the radiation course
- Keloids in areas where radiation therapy introduces unacceptable high risk of toxicity as determined by the treating radiation oncologist
- Uncontrolled intercurrent illness (e.g. symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, or psychiatric situation) that would limit compliance with study requirements as judged by the treatment physicians
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Interventions
RADIATIONRadiotherapy
25 Gy in 5 fractions
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04722263
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