Radiation therapy for treating keloids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the safety and efficacy of radiation therapy (RT) for patients with unresected keloids. It will be conducted at a single institution and will focus on assessing toxicity within 10 weeks, as well as secondary outcomes such as keloid growth cessation, size reduction, symptomatic relief, and quality of life improvements. Patients will receive RT in the form of external beam radiotherapy or brachytherapy, with a total dose of 15 Gy delivered in fractions over three days. The study plans to recruit 15-20 patients over a period of 6-12 months.

Why it matters

Who can join: the full rules

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

Where it's running

• Montefiore Medical Center
  The Bronx, New York, United States Recruiting

Study contacts

• Principal investigator: Keyur J Mehta, MD — Montefiore
• Study coordinator: Keyur Mehta, MD
• Email: kmehta@montefiore.org
• Phone: 917-927-8244

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Online survey about keloid disorder

  This study is trying to gather information from people with keloids about their experiences, family history, and treatments to better understand this condition.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.