Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
15 participants
INTERVENTIONAL
2020-12-01
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Keloid Radiation Registry
NCT01457079
Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid
NCT06431360
Retrospective Study of Keloid Disorder
NCT02923596
A Retrospective Evaluation of Superficial Radiation Therapy (SRT) and Keloid Scars.
NCT03693924
Improving Keloids Using Targeted Ultraviolet-B Irradiation
NCT03160053
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Radiotherapy for patients with nonresectable keloids
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 25 Gy in 5 fractions will be prescribed to the 90% isodose line.
Radiotherapy
25 Gy in 5 fractions
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Radiotherapy
25 Gy in 5 fractions
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Montefiore Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Keyur J Mehta, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Montefiore Medical Center
The Bronx, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Guix B, Henriquez I, Andres A, Finestres F, Tello JI, Martinez A. Treatment of keloids by high-dose-rate brachytherapy: A seven-year study. Int J Radiat Oncol Biol Phys. 2001 May 1;50(1):167-72. doi: 10.1016/s0360-3016(00)01563-7.
Mankowski P, Kanevsky J, Tomlinson J, Dyachenko A, Luc M. Optimizing Radiotherapy for Keloids: A Meta-Analysis Systematic Review Comparing Recurrence Rates Between Different Radiation Modalities. Ann Plast Surg. 2017 Apr;78(4):403-411. doi: 10.1097/SAP.0000000000000989.
Borok TL, Bray M, Sinclair I, Plafker J, LaBirth L, Rollins C. Role of ionizing irradiation for 393 keloids. Int J Radiat Oncol Biol Phys. 1988 Oct;15(4):865-70. doi: 10.1016/0360-3016(88)90119-8.
Bijlard E, Timman R, Verduijn GM, Niessen FB, Hovius SER, Mureau MAM. Intralesional cryotherapy versus excision with corticosteroid injections or brachytherapy for keloid treatment: Randomised controlled trials. J Plast Reconstr Aesthet Surg. 2018 Jun;71(6):847-856. doi: 10.1016/j.bjps.2018.01.033. Epub 2018 Feb 6.
Cheraghi N, Cognetta A Jr, Goldberg D. RADIATION THERAPY for the Adjunctive Treatment of Surgically Excised Keloids: A Review. J Clin Aesthet Dermatol. 2017 Aug;10(8):12-15. Epub 2017 Aug 1.
Renz P, Hasan S, Gresswell S, Hajjar RT, Trombetta M, Fontanesi J. Dose Effect in Adjuvant Radiation Therapy for the Treatment of Resected Keloids. Int J Radiat Oncol Biol Phys. 2018 Sep 1;102(1):149-154. doi: 10.1016/j.ijrobp.2018.05.027. Epub 2018 May 17.
Goutos I, Ogawa R. Brachytherapy in the adjuvant management of keloid scars: literature review. Scars Burn Heal. 2017 Nov 10;3:2059513117735483. doi: 10.1177/2059513117735483. eCollection 2017 Jan-Dec.
Rossi AM, Nehal KS, Lee EH. Radiation-induced Breast Telangiectasias Treated with the Pulsed Dye Laser. J Clin Aesthet Dermatol. 2014 Dec;7(12):34-7.
Malaker K, Vijayraghavan K, Hodson I, Al Yafi T. Retrospective analysis of treatment of unresectable keloids with primary radiation over 25 years. Clin Oncol (R Coll Radiol). 2004 Jun;16(4):290-8. doi: 10.1016/j.clon.2004.03.005.
Kim J, Lee SH. Therapeutic results and safety of postoperative radiotherapy for keloid after repeated Cesarean section in immediate postpartum period. Radiat Oncol J. 2012 Jun;30(2):49-52. doi: 10.3857/roj.2012.30.2.49. Epub 2012 Jun 30.
Lo TC, Seckel BR, Salzman FA, Wright KA. Single-dose electron beam irradiation in treatment and prevention of keloids and hypertrophic scars. Radiother Oncol. 1990 Nov;19(3):267-72. doi: 10.1016/0167-8140(90)90153-n.
Chren MM, Lasek RJ, Sahay AP, Sands LP. Measurement properties of Skindex-16: a brief quality-of-life measure for patients with skin diseases. J Cutan Med Surg. 2001 Mar-Apr;5(2):105-10. doi: 10.1007/BF02737863. Epub 2001 Mar 21.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-11620
Identifier Type: -
Identifier Source: org_study_id
NCT04853433
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.