POST URS Chemotherapy Instillation

Israel Healthcare Foundation

Status

Enrolling

Conditions

UTUC

Treatments

Drug: Mitomycin/Gemcitabine

Drug: Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT06167057

0154-22-CMC-C

Details and patient eligibility

About

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.

Full description

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.

Enrollment

264 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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