Radiotherapy for Keloids

Study Overview
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Brief Summary
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The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids.

Detailed Description
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This will be a 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. Primary Objective -evaluate feasibility and safety of radiation therapy only for the treatment of unresected keloids. Secondary Objectives: To evaluate toxicity of RT for the treatment of unresected keloids. To evaluate response of keloids, either stability or decrease in size, after primary RT. To evaluate symptomatic response of unresected keloids to primary RT. To assess the effect on quality of life of primary RT for unresected keloids 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. We estimate we will be able to recruit 15-20 patients in 6-12 months, thus we are aiming for a sample size of 15 patients. 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.

Official Title
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Primary Radiotherapy for the Treatment of Keloids: A Pilot Study

Conditions
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Keloid

Intervention / Treatment
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* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy for patients with nonresectable keloids<br>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 15 Gy in 3 fractions will be prescribed to the 90% isodose line. | Radiation: Radiotherapy<br>* 15 Gy in 3 fractions<br>* Other names: Radiation therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 1 year post radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 during prescheduled study visits. | Up to 10 weeks (+/- 1 weeks) 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 during prescheduled study visits. | 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 during prescheduled study visits. | Up to 1 year (+/- 1 month) post radiotherapy | 
| Quality of Life as determined by SKINDEX-16 questionnaire | Patient quality of life will be evaulated 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. | Up to 10 weeks (+/- 1 weeks) post radiotherapy | 
| Quality of Life as determined by SKINDEX-16 questionnaire | Patient quality of life will be evaulated 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. | Up to 6 months (+/- 1 month) post radiotherapy | 
| Quality of Life as determined by SKINDEX-16 questionnaire | Patient quality of life will be evaulated 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. | Up to 1 year (+/- 1 month) post radiotherapy |