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

Sponsor

Turku University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01675219

Collaborator

Finnbladder (Other)

400

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Procedure: white light TUR-BT Procedure: blue light TUR-BT Drug: optimized MMC Drug: single immediate chemotherapy instillation	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

bladder cancer recurrence rate [2 years]
any bladder cancer recurrence at 2 years.

Secondary Outcome Measures

Bladder cancer progression [2 years]
bladder cancer progression to T2 or higher
Treatment failure [2 years]
progression, recurrence or side effects preventing completing the trial
mortality [2 years]
death due bladder cancer or other reasons

Other Outcome Measures

costs [2 years]
For analysis of cost-effectiveness. All bladder cancer treatment and treatment complications related costs are included.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country
1	HYKS Peijas Hospital	Helsinki	Finland
2	Hyvinkää District Hospital	Hyvinkää	Finland
3	Kuopio University Hospital	Kuopio	Finland
4	Mikkeli Central Hospital	Mikkeli	Finland
5	Oulu University Hospital	Oulu	Finland
6	Satakunnan keskussairaala	Pori	Finland
7	Seinäjoki Central Hospital	Seinäjoki	Finland
8	Hatanpään sairaala	Tampere	Finland
9	Tampere University Hospital	Tampere	Finland
10	Turku University Hospital	Turku	Finland