EUCTR2016-001186-85-ES进行中（未招募）1 期
HIVEC HR: USE OF CHEMOHYPERTHERMIA WITH INTRAVESICAL MITOMYCIN (HIVEC) FOR THE TREATMENT OF PATIENTS WITH NMIBC AND HIGH RISK (HR) - HIVEC HR
Dr. Felipe Villacampa0 个研究点开始时间: 2016年6月1日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- All
入选标准
- •1. All patients operated of non invasive bladder tumour that meet high
- •risk criteria as per EORTC risk categories
- •2. Above 18 years old
- •3. Accept to participate in the trial and sign the consent form
- •Are the trial subjects under 18? no
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Patients with invasive lesions or CIS
- •2. Hypersensitivity or allergy to MMC
- •3. History of severe adverse reaction to BCG
- •4. Epithelial cells carcinoma involving prostatic urethra or upper urinary
- •5. Patients with tumors histologically different than transitional cell
- •6. Patients that for any reason should receive simultaneous
- •chemotherapy
- •7. Withdrawal of CI
- •8. Pregnant or lactating or women of childbearing age
- •who do not want or can not use non-hormonal contraceptives
- •9. Urethral stenosis that contraindicates catheterization for the
- •instillation
- •10. Treatment with immunosuppressants that contraindicates BCG
研究者
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