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

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ClinicalTrials.gov Identifier: NCT01675219
Recruitment Status : Recruiting
First Posted : August 29, 2012
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
Finnbladder
Information provided by (Responsible Party):
Peter Boström, 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.


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

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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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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




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.



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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)

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


Contacts
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Contact: Peter J Boström, MD, PhD +358 2 313035925 peter.bostrom@tyks.fi
Contact: Riikka Järvinen, MD +358 50 427 1015 riikka.järvinen@hus.fi

Locations
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Finland
HYKS Peijas Hospital Recruiting
Helsinki, Finland
Contact: Riikka Järvinen, MD    +358 50 4271015      
Principal Investigator: Riikka Järvinen, MD         
Hyvinkää District Hospital Recruiting
Hyvinkää, Finland
Contact: Eero Kaasinen, MD       eero.kaasinen@hus.fi   
Principal Investigator: Eero Kaasinen, Md, PhD         
Kuopio University Hospital Recruiting
Kuopio, Finland
Contact: Sirpa Aaltonen, MD       sirpa.aaltonen@kuh.fi   
Principal Investigator: Aaltomaa Sirpa, MD         
Mikkeli Central Hospital Recruiting
Mikkeli, Finland
Contact: Tapani Liukkonen, MD       tapani.liukkonen@esshp.fi   
Principal Investigator: Tapanki Liukkonen, MD         
Oulu University Hospital Recruiting
Oulu, Finland
Contact: Markku Vaarala, MD       markku.vaarala@ppshp.fi   
Principal Investigator: Markku Vaarala, MD         
Satakunnan keskussairaala Recruiting
Pori, Finland
Contact: Marjo Seppänen, MD       marjo.seppanen@satshp.fi   
Principal Investigator: Marjo Seppänen, MD         
Seinäjoki Central Hospital Not yet recruiting
Seinäjoki, Finland
Principal Investigator: Timo Marttila, MD         
Hatanpään sairaala Recruiting
Tampere, Finland
Contact: Tarmo Pekkarinen, MD       tarmo.pekkarinen@pshp.fi   
Principal Investigator: Tarmo Pekkarinen, MD         
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Juha Koskimäki, MD       juha.koskimaki@pshp.fi   
Principal Investigator: Juha Koskimäki, MD         
Turku University Hospital Recruiting
Turku, Finland
Principal Investigator: Peter J. Boström, MD, PhD         
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

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Responsible Party: Peter Boström, MD, PhD, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01675219     History of Changes
Other Study ID Numbers: FinnBladder 9
2012-000559-15 ( EudraCT Number )
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
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
Urinary Bladder Diseases
Urologic Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors