临床试验/NCT02547350

NCT02547350Unknown2 期

Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas

Xuesong Li0 个研究点目标入组 200 人开始时间: 2015年9月最近更新: 2015年9月11日

适应症

干预措施

试验速览

阶段: 2 期
发起方
入组人数: 200
主要终点: intravesical recurrence-free survival

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of prophylactic intravesical chemotherapy (different chemotherapy drugs and dosage regimen) in the prevention of bladder recurrence after nephroureterectomy for upper tract urothelial carcinoma (UTUC).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Patients who were clinically diagnosed with UTUC
•Treated with radical nephroureterectomy

排除标准

•Distant metastasis
•Prior history of bladder or synchronous bladder cancer
•Administration of neoadjuvant chemotherapy
•Presence of severe complications.

研究组 & 干预措施

single intravesical instillation

Experimental

intravesical instillation within 24 hours postoperatively

干预措施: pharmorubicin or pirarubicin (Drug)

multiple intravesical instillation

Experimental

intravesical instillation every 1 week for the first 2 months, then once a month for the rest 10 months

干预措施: pharmorubicin or pirarubicin (Drug)

结局指标

主要结局

intravesical recurrence-free survival

时间窗: two years after surgery

次要结局

cancer-specific survival(two years after surgery)

研究者

发起方

Xuesong Li

申办方类型

Other

责任方

Sponsor Investigator

主要研究者

Xuesong Li

professor

Peking University First Hospital

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