Radiotherapy for Keloids

Montefiore Medical Center15 enrolled

Overview

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: * 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. 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Keloid

Interventions

RadiotherapyRADIATION

25 Gy in 5 fractions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Time frame: Up to 2 weeks (+/- 1 week) post radiotherapy

Cessation of growth or shrinkage of keloids

Time frame: Up to 6 weeks (+/- 1 week) post radiotherapy

Cessation of growth or shrinkage of keloids

Central Contacts

Daniel Alicea

CONTACT

646-538-9909 daniel.alicea2@einsteinmed.edu

Data from ClinicalTrials.gov

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