NCT04722263

Radiotherapy for Keloids

Primary Radiotherapy for the Treatment of Keloids: A Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Keloid

Interventions

Type	Name	Description
RADIATION	Radiotherapy	25 Gy in 5 fractions

Timeline

• Start date: 2020-12-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2021-01-25
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study