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Fluorescence Cystoscopy and Optimized MMC in Recurrent Bladder Cancer (FinnBladder 9)
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
bladder cancer, recurrence, photodynamic diagnosis, PDD, cost analysis
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: white light TUR-BT
Type: Procedure
Name: blue light TUR-BT
Type: Procedure
Name: optimized MMC
Type: Drug
Name: single immediate chemotherapy instillation
Type: Drug
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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)
- 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)
Locations
HYKS Peijas Hospital
Helsinki, Finland
Hyvinkää District Hospital
Status: Recruiting
Contact: Riikka Järvinen, MD - +358 50 4271015
Hyvinkää, Finland
Kuopio University Hospital
Status: Recruiting
Contact: Eero Kaasinen, MD - eero.kaasinen@hus.fi
Kuopio, Finland
Mikkeli Central Hospital
Status: Recruiting
Contact: Sirpa Aaltonen, MD - sirpa.aaltonen@kuh.fi
Mikkeli, Finland
Oulu University Hospital
Status: Recruiting
Contact: Tapani Liukkonen, MD - tapani.liukkonen@esshp.fi
Oulu, Finland
Satakunnan keskussairaala
Status: Recruiting
Contact: Markku Vaarala, MD - markku.vaarala@ppshp.fi
Pori, Finland
Seinäjoki Central Hospital
Status: Recruiting
Contact: Marjo Seppänen, MD - marjo.seppanen@satshp.fi
Seinäjoki, Finland
Hatanpään sairaala
Status: Not yet recruiting
Tampere, Finland
Tampere University Hospital
Status: Recruiting
Contact: Tarmo Pekkarinen, MD - tarmo.pekkarinen@pshp.fi
Tampere, Finland
Turku University Hospital
Status: Recruiting
Contact: Juha Koskimäki, MD - juha.koskimaki@pshp.fi
Turku, Finland
Status: Recruiting
Start Date
December 2012
Completion Date
December 2017
Sponsors
Turku University Hospital
Source
Turku University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page