An interventional study of Radiotherapy in Keloid, sponsored by Montefiore Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Treatment
The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids.
This will be a single-institution pilot study to evaluate the safety and efficacy of radiation therapy (RT) for the treatment of unresected keloids.
Primary Objective:
Evaluate feasibility and safety of radiation therapy only for the treatment of unresected keloids.
Secondary Objectives:
After review of the literature on the use of RT for the treatment of keloids, both resected and unresected, as well as input of expert opinion and clinical experience by the study's radiation oncologists, the RT prescription dose for this study was selected to be 15 Gy, which will be divided into 5 Gy fractions delivered daily over on 3 consecutive days.
Patients will receive RT using external beam radiotherapy (EBRT), delivered via either electrons or megavoltage photons, or brachytherapy; RT modality will be based on the judgment of the treating radiation oncologist. The investigator team estimates that 15-20 patients will be able to be recruited. In successive intervals of enrollment and treatment of 5 patients (i.e., after 5, 10, and 15 patients have been enrolled), the study team will meet and perform interim analysis to evaluate the safety and efficacy of treatment. Investigators will discuss rates of toxicity and symptom management observed up to that point and determine if the study dose or protocol needs to be altered.
Patients will be evaluated frequently for treatment-related toxicities using CTCAE v5.0 up to 1 year after completion of RT. Any adverse event will be considered by the study investigators to evaluate the safety of the protocol and to determine whether changes to the dosing regimen are required.
Once patients have been identified as having a keloid that will not be surgically resected they will be referred to the radiation oncology department at Montefiore Medical Center. Patients will be seen by a treating radiation oncologist and treatment with the assigned dose schedule will be planned using either EBRT with electrons or high dose-rate radiotherapy (HDR) brachytherapy as deemed appropriate by the treating radiation oncologist.
Amendment for increased dose (3/2023): The treatment dose of 25 Gy in 5 fractions will be prescribed to the 90% isodose line. Treatments will be given on consecutive days (Monday through Friday not including weekends), and all efforts will be made to not introduce a weekend break if at between treatment fractions.
Exclusion Criteria:
Patients will be seen by a treating radiation oncologist and treatment with the assigned dose schedule will be planned using either EBRT with electrons or high dose-rate radiotherapy (HDR) brachytherapy as deemed appropriate by the treating radiation oncologist. The treatment dose of 25 Gy in 5 fractions will be prescribed to the 90% isodose line.
Radiation: Radiotherapy
25 Gy in 5 fractions
Also known as: Radiation therapy
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 radiotherapy
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 practicable
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 radiotherapy
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 radiotherapy
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 radiotherapy
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 months (+/- 1 month) post radiotherapy
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 1 year (+/- 1 month) post radiotherapy
Quality of Life as determined by SKINDEX-16 questionnaire
Patient quality of life will be evaluated by responses to a SKINDEX-16 questionnaire. The SKINDEX-16 questionnaire consists of 16 quality of life related questions which score patient responses on a 7-point Likert scale from 0 to 6 where 0 equates to "never bothered" and 6 equates to "always bothered" yielding an overall possible scoring range from 0-96. Lower SKINDEX-16 scores correlate to increased quality of life. Cumulative scores will be summarized and reported using means and standard deviations.
Time frame: During treatment. Assessed as close to the end of the radiotherapy course as practicable, up to ~1 week
Quality of Life as determined by SKINDEX-16 questionnaire
Patient quality of life will be evaluated by responses to a SKINDEX-16 questionnaire. The SKINDEX-16 questionnaire consists of 16 quality of life related questions which score patient responses on a 7-point Likert scale from 0 to 6 where 0 equates to "never bothered" and 6 equates to "always bothered" yielding an overall possible scoring range from 0-96. Lower SKINDEX-16 scores correlate to increased quality of life. Cumulative scores will be summarized and reported using means and standard deviations.
Time frame: Up to 10 weeks (+/- 1 week) post radiotherapy
Quality of Life as determined by SKINDEX-16 questionnaire
Patient quality of life will be evaluated by responses to a SKINDEX-16 questionnaire. The SKINDEX-16 questionnaire consists of 16 quality of life related questions which score patient responses on a 7-point Likert scale from 0 to 6 where 0 equates to "never bothered" and 6 equates to "always bothered" yielding an overall possible scoring range from 0-96. Lower SKINDEX-16 scores correlate to increased quality of life. Cumulative scores will be summarized and reported using means and standard deviations.
Time frame: Up to 6 months (+/- 1 month) post radiotherapy
Quality of Life as determined by SKINDEX-16 questionnaire
Patient quality of life will be evaluated by responses to a SKINDEX-16 questionnaire. The SKINDEX-16 questionnaire consists of 16 quality of life related questions which score patient responses on a 7-point Likert scale from 0 to 6 where 0 equates to "never bothered" and 6 equates to "always bothered" yielding an overall possible scoring range from 0-96. Lower SKINDEX-16 scores correlate to increased quality of life. Cumulative scores will be summarized and reported using means and standard deviations.
Time frame: Up to 1 year (+/- 1 month) post radiotherapy
Plan to share: No
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