Primary Radiotherapy for the Treatment of Keloids: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Treatment-related toxicities
研究概览
简要总结
The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids.
详细描述
This will be a single-institution pilot study to evaluate the safety and efficacy of radiation therapy (RT) for the treatment of unresected keloids.
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •Study specific informed consent provided
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Treatment-related toxicities
时间窗: Up to 1 year (+/- 1 month) post radiotherapy
The number of patients with treatment related toxicities will be determined by the incidence of grade 2 or higher skin-related adverse events based on CTCAE V5.0 criteria during prescheduled study visits. The number of patients with treatment related toxicities will be reported in aggregate for all visits.
次要结局
- Cessation of growth or shrinkage of keloids(Up to 1 year (+/- 1 month) post radiotherapy)
- Quality of Life as determined by SKINDEX-16 questionnaire(Up to 1 year (+/- 1 month) post radiotherapy)
- Cessation of growth or shrinkage of keloids(Week 0, during treatment (as close to the end of the radiotherapy course as practicable)
- Cessation of growth or shrinkage of keloids(Up to 2 weeks (+/- 1 week) post radiotherapy)
- Cessation of growth or shrinkage of keloids(Up to 6 weeks (+/- 1 week) post radiotherapy)
- Cessation of growth or shrinkage of keloids(Up to 10 weeks (+/- 1 week) post radiotherapy)
- Cessation of growth or shrinkage of keloids(Up to 6 months (+/- 1 month) post radiotherapy)
- Quality of Life as determined by SKINDEX-16 questionnaire(During treatment. Assessed as close to the end of the radiotherapy course as practicable, up to ~1 week)
- Quality of Life as determined by SKINDEX-16 questionnaire(Up to 10 weeks (+/- 1 week) post radiotherapy)
- Quality of Life as determined by SKINDEX-16 questionnaire(Up to 6 months (+/- 1 month) post radiotherapy)