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Radiotherapy for Keloids

Primary Purpose

Keloid

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 decline 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

Sites / Locations

  • Montefiore Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy for patients with nonresectable keloids

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of adverse events as assessed by skin and subcutaneous tissue disorders grade 2 or higher using CTCAE criteria
incidence of grade 2 or higher skin AEs using CTCAE criteria at each study visit (before RT, at week 2, week 6, week 10, month 6, 9 and 12)

Secondary Outcome Measures

Full Information

First Posted
January 8, 2021
Last Updated
November 10, 2022
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04722263
Brief Title
Radiotherapy for Keloids
Official Title
Primary Radiotherapy for the Treatment of Keloids: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
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 (see study calendar) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy for patients with nonresectable keloids
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
Radiation therapy
Intervention Description
15 Gy in 3 fractions
Primary Outcome Measure Information:
Title
Incidence of adverse events as assessed by skin and subcutaneous tissue disorders grade 2 or higher using CTCAE criteria
Description
incidence of grade 2 or higher skin AEs using CTCAE criteria at each study visit (before RT, at week 2, week 6, week 10, month 6, 9 and 12)
Time Frame
Up to 12 months post RT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 decline 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Yukelis, BA
Phone
718-920-5636
Email
syukelis@montefiore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keyur J Mehta, MD
Organizational Affiliation
Montefiore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Klein, MD
Phone
718-920-5636
Email
joklein@montefiore.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Radiotherapy for Keloids

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