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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01675219
Recruitment Status : Active, not recruiting
First Posted : August 29, 2012
Last Update Posted : April 13, 2023
Sponsor:
Collaborator:
Finnbladder
Information provided by (Responsible Party):
Peter Boström, Turku University Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2012
Actual Primary Completion Date : December 2021
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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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 Name: 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 Name: 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 Name: optimized mitomycin-C

Drug: single immediate chemotherapy instillation
single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation
Other Name: 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 Name: optimized mitomycin-C

Drug: single immediate chemotherapy instillation
single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation
Other Name: single instillation


Outcome Measures
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Primary Outcome Measures :
  1. bladder cancer recurrence rate [ Time Frame: 2 years ]
    any bladder cancer recurrence at 2 years.


Secondary Outcome Measures :
  1. Bladder cancer progression [ Time Frame: 2 years ]
    bladder cancer progression to T2 or higher

  2. Treatment failure [ Time Frame: 2 years ]
    progression, recurrence or side effects preventing completing the trial

  3. mortality [ Time Frame: 2 years ]
    death due bladder cancer or other reasons


Other Outcome Measures:
  1. costs [ Time Frame: 2 years ]
    For analysis of cost-effectiveness. All bladder cancer treatment and treatment complications related costs are included.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675219


Locations
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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, Finland
Sponsors and Collaborators
Turku University Hospital
Finnbladder
Investigators
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Principal Investigator: Peter J. Boström, MD, PhD Turku University Hospital
Study Director: Eero Kaasinen, Md, PhD Hyvinkää District Hospital
More Information
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Responsible Party: Peter Boström, MD, PhD, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01675219    
Other Study ID Numbers: FinnBladder 9
2012-000559-15 ( EudraCT Number )
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: April 13, 2023
Last Verified: April 2023
Keywords provided by Peter Boström, Turku University Hospital:
bladder cancer
recurrence
photodynamic diagnosis
PDD
cost analysis
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
 Male Urogenital Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors