临床试验/2023-504945-30-00

2023-504945-30-00招募中3 期

Adjuvant instillations in intermediate risk NMIBC: A Study comparIng Gemcitabine and MitomYciN (SIGYN-trial)

Region Skane7 个研究点分布在 1 个国家目标入组 340 人开始时间: 2024年8月30日最近更新: 2024年8月30日

相关药物

试验速览

阶段: 3 期
状态: 招募中
发起方: Region Skane
入组人数: 340
试验地点: 7
主要终点: Recurrence-free survival

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Investigate if adjuvant gemcitabine improves recurrence free survival compared to adjuvant mitomycin

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 years 至 65+ years（65+ Years, 18-64 Years）
接受健康志愿者: 是

入选标准

•Primary and recurrent non muscle invasive bladder cancer with intermediate risk of recurrence

排除标准

•Age below 18 years of age
•lack of informed consent
•Known allergy to either mitomycin or gemcitabine
•Severe incontinence
•Cronic urethral catheter

结局指标

主要结局

Recurrence-free survival

Recurrence-free survival

次要结局

Local toxicity and HRQol two weeks after last installation, Progression-free survival, Health economy, Adverse events

研究者

发起方

申办方类型

Hospital/Clinic/Other health care facility

责任方

Principal Investigator

主要研究者

Fredrik Liedberg

Scientific

Region Skane

研究点 (7)

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