Fluorescence Cystoscopy and Optimized MMC in Recurrent Bladder Cancer (FinnBladder 9)

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of Ta Bladder Cancer in High Risk of Recurrence - Fluorescence Cystoscopy With Optimized Adjuvant Mitomycin-C (FinnBladder 9)

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: white light TUR-BT
* Procedure: blue light TUR-BT
* Drug: optimized MMC
* Drug: single immediate chemotherapy instillation


Participation Criteria
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Eligibility Criteria
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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 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 Exclusion Criteria: 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®) 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group B<br>Blue light TUR-BT with no adjuvant instillations | Procedure: blue light TUR-BT<br>* photodynamic transurethral bladder tumor resection<br>Drug: single immediate chemotherapy instillation<br>* single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation<br>* Other names: single instillation;|
| Active Comparator: Group A<br>White light TUR-BT with no adjuvant instillations | Procedure: white light TUR-BT<br>* traditional transurethral bladder tumor resection<br>Drug: single immediate chemotherapy instillation<br>* single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation<br>* Other names: single instillation;|
| Experimental: Group C<br>White light TUR-BT with six weekly optimized mitomycin-C instillations. | Drug: optimized MMC<br>* six weekly optimized mitomycin-C instillations<br>* Other names: optimized mitomycin-C;Drug: single immediate chemotherapy instillation<br>* single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation<br>* Other names: single instillation;|
| Experimental: Group D<br>Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations. | Procedure: blue light TUR-BT<br>* photodynamic transurethral bladder tumor resection<br>Drug: optimized MMC<br>* six weekly optimized mitomycin-C instillations<br>* Other names: optimized mitomycin-C;Drug: single immediate chemotherapy instillation<br>* single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation<br>* Other names: single instillation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bladder cancer recurrence rate | any bladder cancer recurrence at 2 years. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | 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 | 2 years | 
| mortality | death due bladder cancer or other reasons | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PDD, bladder cancer, recurrence, photodynamic diagnosis, cost analysis