Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 9
- 主要终点
- Complete clinical response
研究概览
简要总结
To evaluate the efficacy (defined as complete clinical response at 6 months) of imiquimod vs. standard treatment (surgery) for vulvar intraepithelial neoplasia (VIN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed VIN (only usual type, formerly VIN 2-3)
- •Visible, measurable lesion(s)
- •Contraception (for premenopausal women)
排除标准
- •Evidence of invasion
- •History of cancer or severe inflammatory dermatosis of the vulva
- •Pregnancy, lactation
- •Immunodeficiency
- •Any treatment for VIN within the previous three months
- •Known hypersensitivity to imiquimod
研究组 & 干预措施
Primary Imiquimod
Treatment with imiquimod will be patient self-administered for a period of 4 months with possible extension to 6 months. A thin layer of imiquimod cream should be applied to the lesion and remain overnight without a cover. Application will be once a week for 2 weeks, then twice a week the following 2 weeks and, if tolerated, 3 times a week for the last weeks. In case of severe side-effects the number of applications can be reduced; a treatment-free period of no more than 1 week is permitted
干预措施: Imiquimod (Drug)
Primary surgery
The type of surgery (excision or ablation) will be based on clinical findings and surgeon's judgement. After excision the specimen will be histologically analyzed to assess resection margins and rule out invasion.
干预措施: Surgery (Procedure)
结局指标
主要结局
Complete clinical response
时间窗: 6 months
No clinical evidence of vulvar lesion, i.e. 100% reduction of primary lesion size
次要结局
- HPV status(12 months)
- Clinical response/ lesion size(6 months)
- Histologic response(6 months)
- Extent of surgery(12 months)
- Clinical response/lesion size(12 months)