Brief Summary
The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids.
Brief Title
Radiotherapy for Keloids
Detailed Description
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.
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.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
646-538-9909
Central Contact Email
daniel.alicea2@einsteinmed.edu
Completion Date
Completion Date Type
Estimated
Conditions
Keloid
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04722263
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2020-11620
Overall Status
Recruiting
Phases
Early Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Primary Radiotherapy for the Treatment of Keloids: A Pilot Study
Primary Outcomes
Outcome Description
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.
Outcome Measure
Treatment-related toxicities
Outcome Time Frame
Up to 1 year post radiotherapy
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Up to 10 weeks (+/- 1 weeks) post radiotherapy
Outcome Measure
Cessation of growth or shrinkage of keloids
Outcome Description
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.
Outcome Time Frame
Up to 6 months (+/- 1 month) post radiotherapy
Outcome Measure
Cessation of growth or shrinkage of keloids
Outcome Description
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.
Outcome Time Frame
Up to 1 year (+/- 1 month) post radiotherapy
Outcome Measure
Cessation of growth or shrinkage of keloids
Outcome Description
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.
Outcome Time Frame
Up to 10 weeks (+/- 1 weeks) post radiotherapy
Outcome Measure
Quality of Life as determined by SKINDEX-16 questionnaire
Outcome Description
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.
Outcome Time Frame
Up to 6 months (+/- 1 month) post radiotherapy
Outcome Measure
Quality of Life as determined by SKINDEX-16 questionnaire
Outcome Description
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.
Outcome Time Frame
Up to 1 year (+/- 1 month) post radiotherapy
Outcome Measure
Quality of Life as determined by SKINDEX-16 questionnaire
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Keyur Mehta
Investigator Email
kmehta@montefiore.org
Investigator Phone
718-405-8560