EUCTR2006-004327-11-GB进行中（未招募）1 期
A randomised phase II multi-centre trial of topical treatment in women with vulval intraepithelial neoplasia - RT3 VI
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Female =16 years
- •2. Biopsy proven VIN 3 (including visible peri-anal disease not extending into the anal canal), biopsy to have been taken within the last three months
- •3. At least one lesion that can be accurately measured (using RECIST criteria) in at least one dimension with longest diameter = 20mm OR in two perpendicular dimensions that when multiplied together give a surface area of greater than 120mm squared
- •4. Using a reliable method of contraception (excluding condoms) if sexually active
- •5 Written informed consent to participate in trial.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any patient with impaired renal function (defined as serum creatinine> 133 µmol/l or > 1.5 mg/dl)
- •2. Any patient with current anogenital carcinoma or any patient who, in the PIs opinion, is at a high risk of developing invasive disease (patients in whom invasive disease or microinvasive disease is suspected should have adequate biopsies to exclude this prior to entry)
- •3. Pregnant, breast feeding or trying to conceive
- •4. Active treatment for VIN within the previous four weeks
- •5. Known allergy to either of the topical treatments or any components in either cream
- •6. Unable to comply with protocol treatment
- •7. Previous failure of imiquimod or cidofovir following treatment three times a week for a minimum of 12 weeks.
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