POST URS Chemotherapy Instillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-17

Study Completion Date

2028-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of UGN-101 in Recurrent Patients

NCT04006691

Carcinoma Transitional Cell Carcinoma Transitional Cell Cancer of the Renal Pelvis and Ureter

WITHDRAWN PHASE3

Intraoperative vs. Postoperative Intravesical Epirubicin Instillation for Prevention of Bladder Recurrence in High-Risk Upper Urinary Tract Urothelial Carcinoma

NCT06941038

Bladder Cancer Recurrence Intravesical Instillation Upper Urinary Tract Carcinoma

COMPLETED

Single-Dose Intravesical Chemotherapy After Diagnostic URS

NCT05810623

Upper Urinary Tract Urothelial Carcinoma Bladder Cancer

NOT_YET_RECRUITING PHASE3

Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma

NCT05979909

Urothelial Carcinoma Ureter Urothelial Cancer of Renal Pelvis

NOT_YET_RECRUITING PHASE1

S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer

NCT00445601

Bladder Cancer

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

UTUC

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter, double arm, single blinded randomized trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Single post-operative MMC 40mg or gemcitabine 2gr in Saline 0.9% 50cc bladder instillation

Group Type EXPERIMENTAL

Mitomycin/Gemcitabine

Intervention Type DRUG

UTUC treatment

B

Single post-operative 50cc Saline 0.9% bladder instillation

Group Type PLACEBO_COMPARATOR

Saline

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No