ACTRN12615001061527撤回3 期
A Randomised Controlled Pilot Study to Assess the Efficacy of Photodynamic Therapy vs. Radiotherapy for the Control of Basal Cell Carcinoma and Bowen's Disease.
St Vincent's Hospital, Sydney0 个研究点目标入组 100 人开始时间: 2015年10月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1 Biopsy-proven superficial BCC or Bowen’s disease.
- •2 De novo lesions; i.e. lesions previously untreated.
- •3 Lesion able to be treated by PDT or RT.
- •4 Lesion originally at least 10mm in maximum dimension(this is to facilitate a single 3mm punch biopsy needed for diagnosis and for an optional translation study based on immunohistochemical staining of the diagnostic biopsy).
- •5 18 years or older.
- •6 Patient is not suitable for surgery either because surgery is too great a burden, the patient is not capable of having surgery (usually due to comorbidity) or has refused surgery.
- •7 Immunosuppressed patients to be included (HIV, Transplant, Auto immune being actively treated (i.e. with chemotherapy (CTX) or steroid dose over 7mg prednisolone equivalent daily) with stratification.
- •8 Life expectancy of at least 2 years.
排除标准
- •1 Lesions unsuitable for PDT or radiotherapy: More infiltrative skin cancers (including nodular, micronodular, infiltrative, morphoeic BCC or infiltrating SCC); Perineural invasion; Subungual lesions; Perioccular lesions unable to be treated by PDT or RT; Larger than PDT field (8x18cm); Pigmented BCC; Genital and perianal lesions
- •2 Aged under 18 years
- •3 Unable to attend treatment for practical reasons
- •4 Porphyria, SLE
- •5 Pregnancy, lactation
- •6 Unable to have RT – e.g. Gorlins, XP.
- •7 Photosensitive disorder to visible light spectrum
- •8 Hypersensitivity to the Metvix cream
- •9 Previous treatment to index lesion
研究者
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