Bladder CancerPhase 3NCT01675219
Fluorescence Cystoscopy and Optimized MMC in Recurrent Bladder Cancer (FinnBladder 9)
A Phase 3 study testing white light TUR-BT, blue light TUR-BT and optimized MMC in people with Bladder Cancer, run by Turku University Hospital at 10 sites in Finland.
Trial summary
Bladder cancer (BC), the second most common urological malignancy, is an important public health issue. One of the main challenges in the treatment of bladder cancer if the prevention of recurrences of non-invasive tumors, which is also associated with significant costs. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- white light TUR-BT, blue light TUR-BT and optimized MMC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 10 sitesFinland
- Study dates
- Dec 2012to Aug 2023
- Phase
- Phase 3
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary papillary bladder cancer at high risk for further recurrence as defined as follows:
- Number of primary tumors ≥2, OR Size of solitary primary tumor ≥ 3 cm, OR Recurrent papillary tumors
- Histologically proven Ta bladder cancer
- Histological grade 1-2 (WHO 1973 grading system) or papillary urothelial neoplasm of low malignant potential (PUNLMP) or low grade (WHO 2004 grading system) bladder cancer
- Written informed consent is required from every eligible patient
Who cannot join
- Grade 3 tumors (WHO 1973 grading system), or high grade tumors (WHO 2004 grading system)
- CIS (carcinoma in situ)
- Suspicion or evidence of papillary tumors or CIS of the upper urinary tract
- Non-TCC (transitional cell carcinoma, i.e. urothelial carcinoma) bladder cancer
- Suspicion or previous history of the patient not tolerating intravesical instillations
- Known allergy to MMC or hexaminolevulinate (HAL, Hexvix®)
Show all 12Show fewer
- Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may compromise study participation (as judged by treating physician)
- Pregnancy or lactating patient
- Other non-cured malignancy (excepting skin basalioma or cancer in situ of the cervix uteri or any other malignancy in remission ≥5 years)
- Age < 18 years
- Expected survival time less than one year
- Expected poor compliance (e.g. some severe psychiatric disorders, antisocial behaviour, or dementia)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Finland10 sites
HYKS Peijas Hospital
Helsinki
Hyvinkää District Hospital
Hyvinkää
Kuopio University Hospital
Kuopio
Mikkeli Central Hospital
Mikkeli
Oulu University Hospital
Oulu
Satakunnan keskussairaala
Pori
Seinäjoki Central Hospital
Seinäjoki
Hatanpään sairaala
Tampere
Tampere University Hospital
Tampere
Turku University Hospital
Turku
About this study
Official title: Treatment of Ta Bladder Cancer in High Risk of Recurrence - Fluorescence Cystoscopy With Optimized Adjuvant Mitomycin-C (FinnBladder 9)
Bladder cancer (BC), the second most common urological malignancy, is an important public health issue. One of the main challenges in the treatment of bladder cancer if the prevention of recurrences of non-invasive tumors, which is also associated with significant costs.
The current study will investigate optimal treatment of patients with bladder cancer with high risk of tumor recurrence but low risk of progression. The main interest is comparison of photodynamic (PDD) bladder tumor resection (TUR-BR)to traditional TUR-BT. Also the efficacy of adjuvant optimized mitomycin-C is compared to patients with no adjuvant treatment.
- Conditions
- Bladder Cancer
- Being tested
- white light TUR-BT, blue light TUR-BT, optimized MMC, single immediate chemotherapy instillation
- Keywords
- bladder cancer, recurrence, photodynamic diagnosis, PDD, cost analysis
- Medical subject headings
- Urinary Bladder Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
white light TUR-BTProcedure or surgery
traditional transurethral bladder tumor resection
blue light TUR-BTProcedure or surgery
photodynamic transurethral bladder tumor resection
optimized MMCDrug
Also called optimized mitomycin-C
six weekly optimized mitomycin-C instillations
single immediate chemotherapy instillationDrug
Also called single instillation
single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation
| Study group | Role | What they receive |
|---|---|---|
| Group B | Experimental | Blue light TUR-BT with no adjuvant instillations Receives: Procedure: blue light TUR-BT; Drug: single immediate chemotherapy instillation |
| Group A | Active comparator | White light TUR-BT with no adjuvant instillations Receives: Procedure: white light TUR-BT; Drug: single immediate chemotherapy instillation |
| Group C | Experimental | White light TUR-BT with six weekly optimized mitomycin-C instillations. Receives: Drug: optimized MMC; Drug: single immediate chemotherapy instillation |
| Group D | Experimental | Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations. Receives: Procedure: blue light TUR-BT; Drug: optimized MMC; Drug: single immediate chemotherapy instillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
bladder cancer recurrence rate
any bladder cancer recurrence at 2 years.
Measured: 2 years
Secondary outcomes (3)
Bladder cancer progression
bladder cancer progression to T2 or higher
Measured: 2 years
Treatment failure
progression, recurrence or side effects preventing completing the trial
Measured: 2 years
mortality
death due bladder cancer or other reasons
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 posted29 Aug 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2021
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Finnbladder
- Responsible party
- Principal investigator, Peter Boström, Turku University Hospital
- Investigators
- Peter J. Boström, MD, PhD, Principal investigator, Turku University HospitalEero Kaasinen, Md, PhD, Study director, Hyvinkää District Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675219
- Sponsor's protocol ID
- FinnBladder 9
- Other IDs
- 2012-000559-15
- Status last verified
- Apr 2023
- First submitted
- 25 Aug 2012
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sell V, Ettala O, Perez IM, Jarvinen R, Pekkarinen T, Vaarala M, Seppanen M, Liukkonen T, Marttila T, Aaltomaa S, Bostrom PJ. Awareness of Smoking as a Risk Factor in Bladder Cancer: Results from the Prospective FinnBladder 9 Trial. Eur Urol Focus. 2022 Sep;8(5):1246-1252. doi: 10.1016/j.euf.2022.01.012. Epub 2022 Jan 31.
PubMed 35094962
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Ta Bladder Cancer in High Risk of Recurrence - Fluorescence Cystoscopy With Optimized Adjuvant Mitomycin-C (FinnBladder 9)
- ClinicalTrials.gov ID
- NCT01675219
- Acronym / sponsor ID
- FinnBladder 9
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer, recurrence, photodynamic diagnosis, PDD, cost analysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Finnbladder
- Study start
- Dec 2012
- Primary completion
- Dec 2021 (actual)
- Study completion
- Aug 2023 (estimated)
- First posted
- 29 Aug 2012 (estimated)
- 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.
Bladder cancer (BC), the second most common urological malignancy, is an important public health issue. One of the main challenges in the treatment of bladder cancer if the prevention of recurrences of non-invasive tumors, which is also associated with significant costs.
The current study will investigate optimal treatment of patients with bladder cancer with high risk of tumor recurrence but low risk of progression. The main interest is comparison of photodynamic (PDD) bladder tumor resection (TUR-BR)to traditional TUR-BT. Also the efficacy of adjuvant optimized mitomycin-C is compared to patients with no adjuvant treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group B | Experimental | Procedure: blue light TUR-BT, Drug: single immediate chemotherapy instillationBlue light TUR-BT with no adjuvant instillations |
| Group A | Active comparator | Procedure: white light TUR-BT, Drug: single immediate chemotherapy instillationWhite light TUR-BT with no adjuvant instillations |
| Group C | Experimental | Drug: optimized MMC, Drug: single immediate chemotherapy instillationWhite light TUR-BT with six weekly optimized mitomycin-C instillations. |
| Group D | Experimental | Procedure: blue light TUR-BT, Drug: optimized MMC, Drug: single immediate chemotherapy instillationBlue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary papillary bladder cancer at high risk for further recurrence as defined as follows:
- Number of primary tumors ≥2, OR Size of solitary primary tumor ≥ 3 cm, OR Recurrent papillary tumors
- Histologically proven Ta bladder cancer
- Histological grade 1-2 (WHO 1973 grading system) or papillary urothelial neoplasm of low malignant potential (PUNLMP) or low grade (WHO 2004 grading system) bladder cancer
- Written informed consent is required from every eligible patient
Key exclusion criteria (12 listed)
- Grade 3 tumors (WHO 1973 grading system), or high grade tumors (WHO 2004 grading system)
- CIS (carcinoma in situ)
- Suspicion or evidence of papillary tumors or CIS of the upper urinary tract
- Non-TCC (transitional cell carcinoma, i.e. urothelial carcinoma) bladder cancer
- Suspicion or previous history of the patient not tolerating intravesical instillations
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 |
|---|---|---|
| white light TUR-BTtraditional transurethral bladder tumor resection | Procedure or surgery | Group A |
| blue light TUR-BTphotodynamic transurethral bladder tumor resection | Procedure or surgery | Group B, Group D |
| optimized MMCAlso: optimized mitomycin-Csix weekly optimized mitomycin-C instillations | Drug | Group C, Group D |
| single immediate chemotherapy instillationAlso: single instillationsingle immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation | Drug | Group A, Group B, Group C, Group D |
Primary outcome
bladder cancer recurrence rate
Time frame: 2 years
any bladder cancer recurrence at 2 years.
3 secondary outcomes
Bladder cancer progression
Time frame: 2 years
Treatment failure
Time frame: 2 years
mortality
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Derived from this study: PubMed 35094962Sell V, Ettala O, Perez IM, Jarvinen R, Pekkarinen T, Vaarala M, Seppanen M, Liukkonen T, Marttila T, Aaltomaa S, Bostrom PJ. Awareness of Smoking as a Risk Factor in Bladder Cancer: Results from the Prospective FinnBladder 9 Trial. Eur Urol Focus. 2022 Sep;8(5):1246-1252. doi: 10.1016/j.euf.2022.01.012. Epub 2022 Jan 31.
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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.
Peter J. Boström, MD, PhD principal investigator
Turku University Hospital
Eero Kaasinen, Md, PhD study director
Hyvinkää District Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing white light TUR-BT, blue light TUR-BT and optimized MMC in people with Bladder Cancer, run by Turku University Hospital at 10 sites in Finland.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 13 Apr 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 Finland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
bladder cancer recurrence rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01675219, which also lists 1 linked publication.
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 13 Apr 2023.