NCT06167057

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Apr 2023Jan 2028

Study Start

First participant enrolled

April 17, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2028

Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

4.8 years

First QC Date

December 4, 2023

Last Update Submit

December 14, 2023

Conditions

UTUC

Keywords

diagnostic URSsingle-dose chemotherapy bladder instillationIVR

Outcome Measures

Primary Outcomes (1)

  • 1 year IVR free survival

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

    1 year

Secondary Outcomes (3)

  • 2 years IVR free survival

    2 years

  • Disease free survival

    2 years

  • High grade (>3) adverse events

    2 years

Study Arms (2)

A

EXPERIMENTAL

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

Drug: Mitomycin/Gemcitabine

B

PLACEBO COMPARATOR

Single post-operative 50cc Saline 0.9% bladder instillation

Drug: Saline

Interventions

Mitomycin/GemcitabineDRUG

UTUC treatment

A
SalineDRUG

UTUC treatment

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Assuta Ashdod Hospital

Ashdod, Israel

RECRUITING

Soroka University Medical Center

Beersheba, Israel

RECRUITING

Shamir Medical Center

Be’er Ya‘aqov, Israel

RECRUITING

Bnai Zion Medical Center

Haifa, 31048, Israel

RECRUITING

Carmel Medical Center

Haifa, 34362, Israel

RECRUITING

Rambam Health Care Campus

Haifa, Israel

RECRUITING

Rabin Medical Center - Beilinson and Hasharon

Petah Tikva, 4937211, Israel

RECRUITING

Kaplan Medical Center

Rehovot, Israel

RECRUITING

Ziv Medical Center

Safed, Israel

RECRUITING

Tel Aviv Sourasky Medical Center - Ichilov

Tel Aviv, Israel

RECRUITING

MeSH Terms

Interventions

MitomycinGemcitabineSodium Chloride

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Yuval Freifeld, Dr

CONTACT

+972-4-8250843yuvalfr@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicenter, double arm, single blinded randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Urologic-Oncology unit, Carmel Medical Center

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 12, 2023

Study Start

April 17, 2023

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

January 30, 2028

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

IL(10)