Clinical trial NCT06167057: POST URS Chemotherapy Instillation
Official title: Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: UTUC
Keywords: diagnostic URS
single-dose chemotherapy bladder instillation
IVR
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, double arm, single blinded randomized trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 1 year IVR free survival
timeFrame: 1 year
Secondary outcomes:
measure: 2 years IVR free survival
timeFrame: 2 years
measure: Disease free survival
timeFrame: 2 years
measure: High grade (>3) adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Ashdod
country: Israel
facility: Assuta Ashdod Hospital
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center
city: Be'er Ya'aqov
country: Israel
facility: Shamir Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Petah Tikva
country: Israel
facility: Rabin Medical Center - Beilinson and Hasharon
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center - Ichilov
city: Zefat
country: Israel
facility: Ziv Medical Center
Study officials:
References: