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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000559-15 | EudraCT Number |
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| Name | Class |
|---|---|
| Finnbladder | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B | Experimental | Blue light TUR-BT with no adjuvant instillations |
|
| Group A | Active Comparator | White light TUR-BT with no adjuvant instillations |
|
| Group C | Experimental | White light TUR-BT with six weekly optimized mitomycin-C instillations. |
|
| Group D | Experimental | Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| white light TUR-BT | Procedure | traditional transurethral bladder tumor resection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| bladder cancer recurrence rate | any bladder cancer recurrence at 2 years. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Bladder cancer progression | bladder cancer progression to T2 or higher | 2 years |
| Treatment failure | progression, recurrence or side effects preventing completing the trial |
| Measure | Description | Time Frame |
|---|---|---|
| costs | For analysis of cost-effectiveness. All bladder cancer treatment and treatment complications related costs are included. | 2 years |
Inclusion Criteria:
- 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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter J. Boström, MD, PhD | Turku University Hospital | Principal Investigator |
| Eero Kaasinen, Md, PhD | Hyvinkää District Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HYKS Peijas Hospital | Helsinki | Finland | ||||
| Hyvinkää District Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35094962 | Derived | 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. |
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| blue light TUR-BT |
| Procedure |
photodynamic transurethral bladder tumor resection |
|
| optimized MMC | Drug | six weekly optimized mitomycin-C instillations |
|
|
| single immediate chemotherapy instillation | Drug | single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation |
|
|
| 2 years |
| mortality | death due bladder cancer or other reasons | 2 years |
| Hyvinkää |
| Finland |
| Kuopio University Hospital | Kuopio | Finland |
| Mikkeli Central Hospital | Mikkeli | Finland |
| Oulu University Hospital | Oulu | Finland |
| Satakunnan keskussairaala | Pori | Finland |
| Seinäjoki Central Hospital | Seinäjoki | Finland |
| Hatanpään sairaala | Tampere | Finland |
| Tampere University Hospital | Tampere | Finland |
| Turku University Hospital | Turku | Finland |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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