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

Phase 3

Active, not recruiting

• Conditions: Bladder Cancer
• Interventions: Drug: optimized MMC; Procedure: blue light TUR-BT; Procedure: white light TUR-BT; Drug: single immediate chemotherapy instillation

• Registration Number: NCT01675219
• Lead Sponsor: Turku University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-25
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-29
• Study Start: 2012-12
• Primary Completion: 2021-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group C	optimized MMC	White light TUR-BT with six weekly optimized mitomycin-C instillations.
Group B	single immediate chemotherapy instillation	Blue light TUR-BT with no adjuvant instillations
Group A	single immediate chemotherapy instillation	White light TUR-BT with no adjuvant instillations
Group C	single immediate chemotherapy instillation	White light TUR-BT with six weekly optimized mitomycin-C instillations.
Group D	single immediate chemotherapy instillation	Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.
Group B	blue light TUR-BT	Blue light TUR-BT with no adjuvant instillations
Group A	white light TUR-BT	White light TUR-BT with no adjuvant instillations
Group D	optimized MMC	Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.
Group D	blue light TUR-BT	Blue light (PDD) TUR-BT with six weekly optimized mitomycin-C instillations.

Primary Outcome Measures

Name	Time	Method
bladder cancer recurrence rate	2 years	any bladder cancer recurrence at 2 years.

Secondary Outcome Measures

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

Trial Locations

Locations (10)

HYKS Peijas Hospital; 🇫🇮 Helsinki, Finland

Seinäjoki Central Hospital; 🇫🇮 Seinäjoki, Finland

Hyvinkää District Hospital; 🇫🇮 Hyvinkää, Finland

Mikkeli Central Hospital; 🇫🇮 Mikkeli, Finland

Hatanpään sairaala; 🇫🇮 Tampere, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

Satakunnan keskussairaala; 🇫🇮 Pori, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland