Radiotherapy for Keloids (NCT04722263) | Clinical Trial Compass
RecruitingNot Applicable
Radiotherapy for Keloids
United States15 participantsStarted 2020-12-01
Plain-language summary
The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Treatment-related toxicities
Timeframe: Up to 1 year (+/- 1 month) post radiotherapy