EUCTR2017-000949-53-NL进行中（未招募）1 期
REduce BlAdder CAncer REcurrence in patients treated for upper urinary tract urothelial carcinoma (REBACARE Trial) - REBACARE TRIA
Erasmus MC, Dept. Urology0 个研究点目标入组 190 人开始时间: 2017年4月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 190
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
- •- Patients with histologically proven urothelial carcinoma of the UUT with or without concurrent carcinoma in situ (CIS only is also allowed) or patients with a suspicion of a urothelial carcinoma of the UUT on CT-scan with or without a urinary cytology sample suspicious of the presence of high-grade urothelial carcinoma. In case urinary cytology shows no abnormality and no diagnostic URS is done, conclusive results of the CT-urography are sufficient for inclusion and the coordinating investigator will evaluate the eligibility of the subject in consultation with the local investigator.
- •- Patients treated either by partial ureterectomy or by a radical nephro-ureterectomy (open or laparoscopic) including a bladder cuff.
- •- Age = 18 years.
- •- WHO performance status 0,1, or 2.
- •- Negative pregnancy test in women with childbearing potential.
- •- Written informed consent.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •- If pre-operative histology obtained by biopsy: aberrant histology of the UUT tumor of >50% (adenocarcinoma, small cell carcinoma, squamous cell carcinoma).
- •- Postoperative pathological report shows absence of tumor (pT0) or >50% of the UUT tumor shows aberrant histology .
- •- History or presence of a malignant tumor or carcinoma in situ of the bladder.
- •- History of UUT urothelial carcinoma on the contralateral side or presence of bilateral UUT urothelial carcinoma.
- •- Known allergy against Mitomycin.
- •- Anticipated adjuvant intravesical treatment with chemo- or immunotherapy.
- •- Anticipated adjuvant intravesical treatment with chemo- or immunotherapy following a diagnostic URS.
- •- Acute urinary tract infection at the time of inclusion as assessed by urinary culturing.
- •- Lymphadenopathy or distant metastases as assessed by preoperative CT-scan of thorax and abdomen.
- •- Any other concurrent severe or uncontrolled disease preventing the safe administration of intravesical Mitomycin.
- •- Breastfeeding women.
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