Bladder CancerPhase 2NCT03058757
The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation
A Phase 2 study testing intravesical mitomycin-C 40mg/20ml instillation in people with Bladder Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate the effectiveness and safety of neoadjuvant intravesical mitomycin-C instillation in non-muscle invasive bladder cancer patients Read more about this study
- Who is it for?
- Ages 20 to 84 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- intravesical mitomycin-C 40mg/20ml instillation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2017to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects who will undergo transurethral resection of the tumor after diagnosis of bladder cancer
- Male or female aged 18 or over 18 years and not more than 85 years who were diagnosed as bladder cancer
- Normal bone marrow function: Hemoglobin >10 g/dL, ANC >1,500/mm3, platelet count>100,000/mm3
- Normal renal function: serum creatinine ≤ 1.4 mg/dL
- Normal liver function:
- Bilirubin ≤ 1.5 times of upper normal limit
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- AST/ALT ≤ 1.8 times of upper normal limit
- Alkaline phosphatase ≤ 1.8 times of upper normal limit
- Subjects who voluntarily decided to participate and signed the written informed consent
Who cannot join
- Non-urothelial carcinoma
- Muscle invasive bladder cancer
- Subjects who underwent intravesical mitomycin-C instillation after diagnosis of bladder cancer within 3 years
- Prior hypersensitivity reaction history to mitomycin-C
- Neurogenic bladder
- Subjects who underwent chemotherapy due to any cancer within 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation in Non-muscle Invasive Bladder Cancer Patients: Prospective, Randomized, Phase II Study
The aim of this study is to evaluate the effectiveness and safety of neoadjuvant intravesical mitomycin-C instillation in non-muscle invasive bladder cancer patients
Read the detailed description
Study Design: Intervention Model: Single Group Assignment Masking: Open Label
Primary Outcome Measures:
Recurrence-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.
Secondary Outcome Measures:
Progression-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.
Time to recurrence in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.
Change of tumor size after neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.
Safety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.
- Conditions
- Bladder Cancer
- Being tested
- intravesical mitomycin-C 40mg/20ml instillation
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravesical mitomycin-C 40mg/20ml instillationDrug
Also called Mitomycin_C Kyowa
neoadjuvant Intravesical mitomycin-C 40mg/20ml instillation
- one day before surgery
- four hours before surgery
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | No intervention applied. |
| Intervention arm | Experimental | neoadjuvant intravesical mitomycin-C 40mg/20ml instillation Receives: Drug: intravesical mitomycin-C 40mg/20ml instillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Recurrence will be assessed by CT scan and cystoscopic exam.
Pathologic recurrence free survival after transurethral resection
Measured: 1 year
Secondary outcomes (4)
Progression-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Progression will be assessed by CT scan.
Pathologic or radiologi progression free survival after transurethral resection
Measured: 1 years
Time to recurrence in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Recurrence will be assessed by CT scan and cystoscopic exam.
Period of from transurethral resection to first pathologic recurrence
Measured: 1 years
Change of tumor size after neoadjuvant intravesical mitomycin-C 40mg/20ml instillation. Change of tumor size will be assessed by CT scan and cystoscopic exam.
Change of tumor size at the time point of diagnostic cystoscope to transurethral resection
Measured: 1 years
Safety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.
Safety will be assessed by International Prostate Symptom Score (IPSS; 0-7, mildly symptomatic; 8-19, moderately symptomatic; 20-35 severely symptomatic) and treatment delay
Measured: six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Feb 2017
- Primary completion18 Feb 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ho Kyung Seo, National Cancer Center, Korea
- Investigators
- Ho Kyung Seo, M.D., Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058757
- Sponsor's protocol ID
- NeoadjMitomycin-C
- Status last verified
- Jan 2023
- First submitted
- 15 Feb 2017
- Last updated
- 31 Jan 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 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Neoadjuvant Intravesical Mitomycin-C Instillation in Non-muscle Invasive Bladder Cancer Patients: Prospective, Randomized, Phase II Study
- ClinicalTrials.gov ID
- NCT03058757
- Acronym / sponsor ID
- NeoadjMitomycin-C
- Conditions
- Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Feb 2017 (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 aim of this study is to evaluate the effectiveness and safety of neoadjuvant intravesical mitomycin-C instillation in non-muscle invasive bladder cancer patients
Detailed description
Study Design: Intervention Model: Single Group Assignment Masking: Open Label
Primary Outcome Measures:
Recurrence-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.
Secondary Outcome Measures:
Progression-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.
Time to recurrence in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group.
Change of tumor size after neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.
Safety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –No intervention applied. |
| Intervention arm | Experimental | Drug: intravesical mitomycin-C 40mg/20ml instillationneoadjuvant intravesical mitomycin-C 40mg/20ml instillation |
Who may qualify
- Ages
- 20 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The subjects who will undergo transurethral resection of the tumor after diagnosis of bladder cancer
- Male or female aged 18 or over 18 years and not more than 85 years who were diagnosed as bladder cancer
- Normal bone marrow function: Hemoglobin >10 g/dL, ANC >1,500/mm3, platelet count>100,000/mm3
- Normal renal function: serum creatinine ≤ 1.4 mg/dL
- Normal liver function:
Key exclusion criteria (6 listed)
- Non-urothelial carcinoma
- Muscle invasive bladder cancer
- Subjects who underwent intravesical mitomycin-C instillation after diagnosis of bladder cancer within 3 years
- Prior hypersensitivity reaction history to mitomycin-C
- Neurogenic bladder
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 |
|---|---|---|
| intravesical mitomycin-C 40mg/20ml instillationAlso: Mitomycin_C Kyowaneoadjuvant Intravesical mitomycin-C 40mg/20ml instillation * one day before surgery * four hours before surgery | Drug | Intervention arm |
Primary outcome
Recurrence-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Recurrence will be assessed by CT scan and cystoscopic exam.
Time frame: 1 year
Pathologic recurrence free survival after transurethral resection
4 secondary outcomes
Progression-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Progression will be assessed by CT scan.
Time frame: 1 years
Time to recurrence in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Recurrence will be assessed by CT scan and cystoscopic exam.
Time frame: 1 years
Change of tumor size after neoadjuvant intravesical mitomycin-C 40mg/20ml instillation. Change of tumor size will be assessed by CT scan and cystoscopic exam.
Time frame: 1 years
Safety of neoadjuvant intravesical mitomycin-C 40mg/20ml instillation.
Time frame: six years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ho Kyung Seo, M.D. principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intravesical mitomycin-C 40mg/20ml instillation in people with Bladder Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
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 9 inclusion and 6 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: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival in neoadjuvant intravesical mitomycin-C 40mg/20ml instillation group and control group. Recurrence will be assessed by CT scan and cystoscopic exam. (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 31 Jan 2023.