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Recruiting NCT06167057

POST URS Chemotherapy Instillation

No phase Interventional UTUC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mitomycin/Gemcitabine, Saline.
Who it may be relevant to
Registry conditions: UTUC. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Mitomycin/Gemcitabine
    UTUC treatment
  • Drug Saline
    UTUC treatment

Primary outcome measures

  • 1 year IVR free survival [Time frame: 1 year]
Secondary outcome measures (3)
  • 2 years IVR free survival [Time frame: 2 years]
  • Disease free survival [Time frame: 2 years]
  • High grade (>3) adverse events [Time frame: 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Israel · 10 centers
  • Assuta Ashdod Hospital — Ashdod
  • Soroka University Medical Center — Beersheba
  • Shamir Medical Center — Be’er Ya‘aqov
  • Bnai Zion Medical Center — Haifa
  • Carmel Medical Center — Haifa
  • Rambam Health Care Campus — Haifa
  • Rabin Medical Center - Beilinson and Hasharon — Petah Tikva
  • Kaplan Medical Center — Rehovot
  • … and 2 more centers

Identifiers

NCT: NCT06167057 · 0154-22-CMC-C

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗