Status:
RECRUITING
Radiotherapy for Keloids
Lead Sponsor:
Montefiore Medical Center
Conditions:
Keloid
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 wee...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04722263
Start Date
December 1 2020
End Date
June 1 2026
Last Update
January 13 2025
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467