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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01675219
• Other study ID #: FinnBladder 9
• Secondary ID: 2012-000559-15
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 2012
• Est. completion date: August 2023

Study information

• Verified date: April 2023
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: August 2023
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• white light TUR-BT
traditional transurethral bladder tumor resection
• blue light TUR-BT
photodynamic transurethral bladder tumor resection

Drug:
• optimized MMC
six weekly optimized mitomycin-C instillations
• single immediate chemotherapy instillation
single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation

Locations

Country	Name	City	State
Finland	HYKS Peijas Hospital	Helsinki
Finland	Hyvinkää District Hospital	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

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	Finnbladder

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	costs	For analysis of cost-effectiveness. All bladder cancer treatment and treatment complications related costs are included.	2 years
Primary	bladder cancer recurrence rate	any bladder cancer recurrence at 2 years.	2 years
Secondary	Bladder cancer progression	bladder cancer progression to T2 or higher	2 years
Secondary	Treatment failure	progression, recurrence or side effects preventing completing the trial	2 years
Secondary	mortality	death due bladder cancer or other reasons	2 years