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NCT Number: NCT06167057

POST URS Chemotherapy Instillation

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assuta Ashdod Hospital, Ashdod, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mitomycin/Gemcitabine

Drug

UTUC treatment

Saline

Drug

UTUC treatment

Primary outcomes

  1. 1 year IVR free survival

    Time frame: 1 year

    no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for 1 year

Secondary outcomes

  1. 2 years IVR free survival

    Time frame: 2 years

    no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for second year

  2. Disease free survival

    Time frame: 2 years

  3. High grade (>3) adverse events

    Time frame: 2 years

    Adverse events that are severe or medically significant but not immediately life threatening

Study contacts

Contact information is provided by the study sponsor or research team.

Yuval Freifeld, Dr

CONTACT

[email protected]

+972-4-8250843

Sponsors and collaborators

Lead sponsor

Carmel Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 12, 2023
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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