UTUCNCT06167057
POST URS Chemotherapy Instillation
A study testing Mitomycin/Gemcitabine and Saline in people with UTUC, run by Carmel Medical Center at 10 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- UTUC
- What is being tested?
- Mitomycin/Gemcitabine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 10 sitesIsrael
- Study dates
- 17 Apr 2023to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Israel10 sites, 10 recruiting
- Recruiting
Assuta Ashdod Hospital
Ashdod
Dor Golomb, Dr, golombdor@gmail.com
- Recruiting
Shamir Medical Center
Be’er Ya‘aqov
Amnon Zisman, Prof, AmnonZ@shamir.gov.il
- Recruiting
Soroka University Medical Center
Beersheba
Jonathan Wagmaister, Dr, jonathanwa@clalit.org.il
- Recruiting
Bnai Zion Medical Center
Haifa, 31048
Zaher Bahouth, Dr, zaher.bahouth@gmail.com
- Recruiting
Carmel Medical Center
Haifa, 34362
Yuval Freifeld, Dr., Yuvalfr@clalit.org.il
Yuval Freifeld, Dr.
- Recruiting
Rambam Health Care Campus
Haifa
Michael Mullerad, Dr, M_MULLERAD@rambam.health.gov.il
- Recruiting
Rabin Medical Center - Beilinson and Hasharon
Petah Tikva, 4937211
David Lifshitz, Prof, davidlif@clalit.org.il
- Recruiting
Kaplan Medical Center
Rehovot
Yaniv Shilo, Dr, MRYANIVSH@clalit.org.il
- Recruiting
Ziv Medical Center
Safed
Ran Katz, Dr, rank@ziv.gov.il
- Recruiting
Tel Aviv Sourasky Medical Center - Ichilov
Tel Aviv
Ziv Savin, Dr, zivsavin23@gmail.com
About this study
Official title: Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence
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.
Read the 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.
- Conditions
- UTUC
- Being tested
- Mitomycin/Gemcitabine, Saline
- Keywords
- diagnostic URS, single-dose chemotherapy bladder instillation, IVR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin/GemcitabineDrug
UTUC treatment
SalineDrug
UTUC treatment
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Single post-operative MMC 40mg or gemcitabine 2gr in Saline 0.9% 50cc bladder instillation Receives: Drug: Mitomycin/Gemcitabine |
| B | Placebo comparator | Single post-operative 50cc Saline 0.9% bladder instillation Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year IVR free survival
no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for 1 year
Measured: 1 year
Secondary outcomes (3)
2 years IVR free survival
no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for second year
Measured: 2 years
Disease free survival
Measured: 2 years
High grade (>3) adverse events
Adverse events that are severe or medically significant but not immediately life threatening
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start17 Apr 2023
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UTUCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, double arm, single blinded randomized trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuval Freifeld, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167057
- Sponsor's protocol ID
- 0154-22-CMC-C
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence
- ClinicalTrials.gov ID
- NCT06167057
- Acronym / sponsor ID
- 0154-22-CMC-C
- Conditions
- UTUC
- Keywords
- diagnostic URS, single-dose chemotherapy bladder instillation, IVR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multicenter, double arm, single blinded randomized trial
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Mitomycin/GemcitabineSingle post-operative MMC 40mg or gemcitabine 2gr in Saline 0.9% 50cc bladder instillation |
| B | Placebo comparator | Drug: SalineSingle post-operative 50cc Saline 0.9% bladder instillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitomycin/GemcitabineUTUC treatment | Drug | A |
| SalineUTUC treatment | Drug | B |
Primary outcome
1 year IVR free survival
Time frame: 1 year
no intravesical recurrence of Upper Tract Urothelial Carcinoma in a patient for 1 year
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for UTUC
RecruitingObservational study
A Comprehensive Prospective Assessment of the Physical and Biological Effects of Upper Tract Urothelial Cancer (UTUC)
Upper Tract Urothelial Cancer
RecruitingPhase 2
Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma
Low Grade Upper Tract Urothelial Carcinoma
RecruitingPhase 3
Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)
Bladder Cancer, Bladder Urothelial Carcinoma
RecruitingObservational study
uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
Urothelial Carcinoma, Urothelial Carcinoma Recurrent
RecruitingPhase 3
Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma
Upper Tract Urothelial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitomycin/Gemcitabine and Saline in people with UTUC, run by Carmel Medical Center at 10 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuval Freifeld, Dr (+972-4-8250843, yuvalfr@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year IVR free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.