NCT05135052进行中（未招募）不适用
Efficacy of Personalised Irradiation With Rhenium-Skin Cancer Therapy (SCT) for the Treatment of Non-Melanoma Skin Cancer: A Phase IV, Multi-Centre, International, Open-Label, Single Arm Study.
OncoBeta Therapeutics13 个研究点 分布在 5 个国家目标入组 210 人开始时间: 2022年1月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
- 试验地点
- 13
- 主要终点
- Complete Response (CR) with Modified Visual RECIST tool
研究概览
简要总结
Efficacy of Personalised Irradiation with Rhenium-Skin Cancer Therapy (SCT) for the treatment of non-melanoma skin cancer; a phase IV multi-centre, international, open label, single arm study.
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
- •Stage I or II BCC or SCC (SCC Well to Moderately Differentiated), and clinically node negative disease
- •Confirmed Histology, and with depth of lesion noted
- •Subjects with up to 3 lesions suitable to enter the study (subjects with more than 3 lesions are not excluded from the study, however 3 target lesions are determined for study evaluation only.)
- •Subjects able and willing to comply with the requirements of the study
- •Age >=18 years
- •Informed Consent signed by the subject consenting to undergo the study
- •Lesions up to 8cm2
- •Lesions with a depth up to 3mm confirmed on biopsy report AND deemed appropriate clinically by treating clinician
- •Subjects who are not deemed suitable for surgery, for example due to tumour location, performance status or other comorbidities as deemed relevant by the treating clinician
- •Patients who may have declined Surgery and/or fractionated Radiation Therapy
排除标准
- •Inability to personally provide written informed consent or to understand and collaborate throughout the study
- •Inability or unwillingness to comply with study requirements
- •Prior treatment with surgery or radiation therapy for their target lesion(s)
- •Depth of lesion greater than 3mm as defined by Biopsy and/or clinical assessment
- •Lupus and Scleroderma
- •Basal cell naevus syndrome, xeroderma, vitiligo and albinism
- •Prior laser at the tumour site
- •Malignant melanoma systemic therapy ongoing
- •Any ongoing treatment for malignancy, or in the last 4 weeks prior to study entry
- •A tumour affecting nerves or bony structures
- •Clinical concern of metastatic disease
- •Pregnancy and/or Lactation
- •Pathological exclusions: Perineural Invasion, Lymphovascular invasion
- •Anatomical exclusions: NMSC's of the Medial canthus, eyelid margin (upper and lower), Vermillion lip
结局指标
主要结局
Complete Response (CR) with Modified Visual RECIST tool
时间窗: 12 months
To assess the proportion of lesions achieving complete response (CR) as per MODIFIED VISUAL RECIST criteria
次要结局
- SKINDEX-16 QoL Questionnaire(6 months and 12 months)
- Comfort of Treatment short questionnaire(14 days)
- cosmetic outcomes by Visual Analogue Scale(12 months and 24 months)
研究者
研究点 (13)
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