Urothelial Carcinoma UreterPhase 1NCT05979909
Intravesical Mitomycin C After Diagnostic Ureteroscopy for Upper Tract Urothelial Carcinoma
A Phase 1 study testing Mitomycin C in people with Urothelial Carcinoma Ureter and Urothelial Cancer of Renal Pelvis, run by McMaster University.
Trial summary
The objective of this pilot study is to determine the feasibility of conducting a phase III randomized trial of intravesical mitomycin C (MMC) for prevention of intravesical recurrence (IVR) after diagnostic ureteroscopy for suspected upper tract urothelial carcinoma (UTUC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma Ureter, Urothelial Cancer of Renal Pelvis
- What is being tested?
- Mitomycin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Sep 2027
- Phase
- Phase 1
- 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
- Suspected upper tract urothelial carcinoma (UTUC)
- Diagnostic ureteroscopy required
- Tumor suggestive of upper tract urothelial carcinoma (UTUC) found on ureteroscopy
Who cannot join
- Prior or concomitant urothelial carcinoma of the bladder
- History of UTUC
- Ureteroscopy within the preceding six months
- Untreated urinary tract infection
- Suspected or confirmed perforation of the upper or lower urinary tract
- Lower urinary tract fistula
Show all 11Show fewer
- Leukopenia or thrombocytopenia
- ECOG performance status 2 or greater
- Known hypersensitivity to mitomycin C
- Pregnancy or breastfeeding
- Lack of capacity to consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preventing Intravesical Recurrence in Patients With Urothelial Carcinoma of the Upper Urinary Tract: a Pilot Randomized Trial of a Single Prophylactic Bladder Instillation of Mitomycin C After Diagnostic Ureteroscopy
The objective of this pilot study is to determine the feasibility of conducting a phase III randomized trial of intravesical mitomycin C (MMC) for prevention of intravesical recurrence (IVR) after diagnostic ureteroscopy for suspected upper tract urothelial carcinoma (UTUC). In the current study, 40 patients will be randomized to receive MMC or no intervention and will be followed for two years to determine the incidence of adverse events and IVR.
- Being tested
- Mitomycin C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin CDrug
Mitomycin (40 mg in 40 mL of sterile water) will be administered through a Foley catheter, which will be clamped for two hours.
| Study group | Role | What they receive |
|---|---|---|
| Intravesical mitomycin C (MMC) | Experimental | Not described Receives: Drug: Mitomycin C |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of patients who consent to participate in the study after being invited to do so
Measured: 30 days
Randomization rate
Proportion of consented patients who are deemed eligible to participate and are randomly allocated to one of the two arms
Measured: 30 days
Retention rate
Proportion of randomized patients who complete follow-up
Measured: 2 years
Secondary outcomes (3)
Adverse events (any)
Cumulative incidence of adverse events
Measured: 30 days
Adverse events (severe)
Cumulative incidence of grade 3-5 adverse events
Measured: 30 days
Intravesical recurrence
Cumulative incidence of urothelial carcinoma of the bladder
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 posted7 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial Carcinoma UreterStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979909
- Sponsor's protocol ID
- 14728
- Status last verified
- Jul 2023
- First submitted
- 31 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- 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 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Intravesical Recurrence in Patients With Urothelial Carcinoma of the Upper Urinary Tract: a Pilot Randomized Trial of a Single Prophylactic Bladder Instillation of Mitomycin C After Diagnostic Ureteroscopy
- ClinicalTrials.gov ID
- NCT05979909
- Acronym / sponsor ID
- 14728
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 7 Aug 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 objective of this pilot study is to determine the feasibility of conducting a phase III randomized trial of intravesical mitomycin C (MMC) for prevention of intravesical recurrence (IVR) after diagnostic ureteroscopy for suspected upper tract urothelial carcinoma (UTUC). In the current study, 40 patients will be randomized to receive MMC or no intervention and will be followed for two years to determine the incidence of adverse events and IVR.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravesical mitomycin C (MMC) | Experimental | Drug: Mitomycin C |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Suspected upper tract urothelial carcinoma (UTUC)
- Diagnostic ureteroscopy required
- Tumor suggestive of upper tract urothelial carcinoma (UTUC) found on ureteroscopy
Key exclusion criteria (11 listed)
- Prior or concomitant urothelial carcinoma of the bladder
- History of UTUC
- Ureteroscopy within the preceding six months
- Untreated urinary tract infection
- Suspected or confirmed perforation of the upper or lower urinary tract
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 CMitomycin (40 mg in 40 mL of sterile water) will be administered through a Foley catheter, which will be clamped for two hours. | Drug | Intravesical mitomycin C (MMC) |
Primary outcome
Recruitment rate
Time frame: 30 days
Proportion of patients who consent to participate in the study after being invited to do so
Randomization rate
Time frame: 30 days
Proportion of consented patients who are deemed eligible to participate and are randomly allocated to one of the two arms
Retention rate
Time frame: 2 years
Proportion of randomized patients who complete follow-up
3 secondary outcomes
Adverse events (any)
Time frame: 30 days
Adverse events (severe)
Time frame: 30 days
Intravesical recurrence
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 7 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Urothelial Carcinoma Ureter
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 2/3
Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
Renal Pelvis and Ureter Urothelial Carcinoma
RecruitingPhase 1
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Urinary Bladder Neoplasms, Neoplasm Metastasis
RecruitingPhase 1
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Metastatic Solid Tumor, Recurrent Solid Tumor
Not yet recruitingPhase 2
Neoadjuvant Disitamab Vedotin, Toripalimab, and Radiotherapy for High-risk UTUC ( LUXUS07.1 )
Urothelial Carcinoma of the Renal Pelvis and Ureter, Neoadjuvant Therapy
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mitomycin C in people with Urothelial Carcinoma Ureter and Urothelial Cancer of Renal Pelvis, run by McMaster University.
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 3 inclusion and 11 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: opening soon, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Piotr Zareba, MD MPH ((905) 521-2100 ext. 47109, zareba@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 30 days). The study lists 3 primary outcomes in all. 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 7 Aug 2023.