POST URS Chemotherapy Instillation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence

Conditions
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UTUC

Intervention / Treatment
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* Drug: Mitomycin/Gemcitabine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, double arm, single blinded randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Single post-operative MMC 40mg or gemcitabine 2gr in Saline 0.9% 50cc bladder instillation | Drug: Mitomycin/Gemcitabine<br>* UTUC treatment<br>|
| Placebo Comparator: B<br>Single post-operative 50cc Saline 0.9% bladder instillation | Drug: Saline<br>* UTUC treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 year IVR free survival | no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for 1 year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 years IVR free survival | no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for second year | 2 years | 
| Disease free survival |  | 2 years | 
| High grade (>3) adverse events | Adverse events that are severe or medically significant but not immediately life threatening | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diagnostic URS, single-dose chemotherapy bladder instillation, IVR