Radiotherapy for Keloids
ConditionKeloid
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Radiotherapy
Radiation25 Gy in 5 fractions
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Radiotherapy for patients with nonresectable keloidsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment-related toxicities
The number of patients with treatment related toxicities will be determined by the incidence of grade 2 or higher skin-related adverse events based on CTCAE V5.0 criteria during prescheduled study visits. The number of patients with treatment related toxicities will be reported in aggregate for all visits.
Time frame
Up to 1 year (+/- 1 month) post radiotherapySecondary outcomes
1
Cessation of growth or shrinkage of keloids
The number of patients demonstrating cessation of growth or shrinkage of keloids as compared to baseline will be determined by measurements of the three dimensions of the keloid (maximum length, width, and height off the skin) during prescheduled study visits.
Time frame
Week 0, during treatment (as close to the end of the radiotherapy course as practicable2
Cessation of growth or shrinkage of keloids
The number of patients demonstrating cessation of growth or shrinkage of keloids as compared to baseline will be determined by measurements of the three dimensions of the keloid (maximum length, width, and height off the skin) during prescheduled study visits.
Time frame
Up to 2 weeks (+/- 1 week) post radiotherapy3
Cessation of growth or shrinkage of keloids
The number of patients demonstrating cessation of growth or shrinkage of keloids as compared to baseline will be determined by measurements of the three dimensions of the keloid (maximum length, width, and height off the skin) during prescheduled study visits.
Time frame
Up to 6 weeks (+/- 1 week) post radiotherapy4
Cessation of growth or shrinkage of keloids
The number of patients demonstrating cessation of growth or shrinkage of keloids as compared to baseline will be determined by measurements of the three dimensions of the keloid (maximum length, width, and height off the skin) during prescheduled study visits.
Time frame
Up to 10 weeks (+/- 1 week) post radiotherapySponsors and contacts
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Source ClinicalTrials.gov