Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 10
- 主要终点
- 1 year IVR free survival
研究概览
简要总结
The goal of this study is to evaluate the safety and oncological outcomes of single chemotherapy bladder instillation following endoscopic treatment for UTUC in UTUC suspected patients .The main aim is to determine the efficacy of a single, post URS, chemotherapy bladder instillation to reduce IVR.
Participants will be given single chemotherapy bladder instillation within 24h following ureteroscopy and will follow routine follow-up for IVR which will include white light cystoscopy ;patients with suspected IVR (based on either imaging or cystoscopy) will undergo TURBT.
详细描述
URS is routinely used for both diagnosis and treatment of UTUC - it is used either as an initial diagnostic procedure or as a curative procedure in cases amenable for endoscopic tumor ablation; either with low-risk disease or an imperative indication due to impaired renal function.
Following extirpative surgery patients are prone to IVR. Those patients undergo routine follow-up with cystoscopy and in cases of IVR require TURBT and further management based on bladder cancer protocols. In this setting, a single post-operative bladder instillation with various chemotherapeutic agents has shown a significant reduction in IVR rates following RNU.
Retrospective evidence suggests there is an increase IVR rates following URS for UTUC.
In this study the investigators seek to evaluate the efficacy of a single, post URS, bladder instillation with chemotherapy to reduce IVR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiographic and/or cytological suspicion for UTUC
- •Planned endoscopic procedure for treatment / diagnosis of UTUC
- •Patients with bladder cancer history are eligible if meeting both following criteria:
- •No recurrence within the last two years Are not on active bladder irrigation protocol
- •Patients with history of UTUC are eligible if last endoscopic treatment or RNU was >1 year prior to enrollment
- •Age ≥ 18 years
- •Performance status ECOG 0-2
排除标准
- •Subjects who have had bladder / prostate radiotherapy
- •Subjects with bladder cancer history on active bladder irrigation protocols or with active disease within two years prior to enrollment
- •Subjects with previously treated UTUC within one year prior to enrollment
- •Subjects with metastatic disease
研究组 & 干预措施
A
Single post-operative MMC 40mg or gemcitabine 2gr in Saline 0.9% 50cc bladder instillation
干预措施: Mitomycin/Gemcitabine (Drug)
B
Single post-operative 50cc Saline 0.9% bladder instillation
干预措施: Saline (Drug)
结局指标
主要结局
1 year IVR free survival
时间窗: 1 year
no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for 1 year
次要结局
- 2 years IVR free survival(2 years)
- Disease free survival(2 years)
- High grade (>3) adverse events(2 years)
研究者
Yuval Freifeld
Head of Urologic-Oncology unit, Carmel Medical Center
Carmel Medical Center