RecruitingNot ApplicableNCT04722263

Radiotherapy for Keloids

Primary Radiotherapy for the Treatment of Keloids: A Pilot Study


Sponsor

Montefiore Medical Center

Enrollment

15 participants

Start Date

Dec 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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

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Interventions

RADIATIONRadiotherapy

25 Gy in 5 fractions


Locations(1)

Montefiore Medical Center

The Bronx, New York, United States

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NCT04722263


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