EUCTR2012-000559-15-FI
Active, not recruiting
Not Applicable
TREATMENT OF Ta BLADDER CANCER WITH HIGH RISK OF RECURRENCE – FLUORESCENCE CYSTOSCOPY WITH OPTIMIZED ADJUVANT MITOMYCIN-C - FLUORESCENCE CYSTOSCOPY AND OPTIMIZED MMC IN RECURRENT BLADDER CANCER (FINNBLADDER 9)
FinnBladder0 sitesAugust 23, 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- bladder cancer (non-invasive Ta urothelial bladder cancer)
- Sponsor
- FinnBladder
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Primary papillary bladder cancer at high risk for further recurrence
- •\- Number of primary tumors \=2, OR
- •\- Size of solitary primary tumor \= 3 cm, OR
- •\-Recurrent papillary tumors
- •2\) Histologically proven Ta bladder cancer
- •3\) 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
- •4\) Written informed consent is required from every eligible patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\) Grade 3 tumors (WHO 1973 grading system), or high grade tumors (WHO 2004 grading system)
- •2\) CIS (carcinoma in situ)
- •3\) Suspicion or evidence of papillary tumors or CIS of the upper urinary tract
- •4\) Non\-TCC (transitional cell carcinoma, i.e. urothelial carcinoma) bladder cancer
- •5\) Suspicion or previous history of the patient not tolerating intravesical instillations
- •6\) Known allergy to MMC or hexaminolevulinate (HAL, Hexvix®)
- •7\) Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may compromise study participation (as judged by treating physician)
- •8\) Pregnancy or lactating patient
- •9\) Other non\-cured malignancy (excepting skin basalioma or cancer in situ of the cervix uteri or any other malignancy in remission \=5 years)
- •10\) Age \< 18 years
Outcomes
Primary Outcomes
Not specified
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