TREATMENT OF NON-INVASIVE BLADDER CANCER WITH HIGH RISK OF RECURRENCE – BLUE LIGHT CYSTOSCOPY WITH CHEMOTHERAPY

• Conditions: bladder cancer (non-invasive Ta urothelial bladder cancer); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000559-15-FI
• Lead Sponsor: FinnBladder

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-23
• Last Update Posted: 18 September 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

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
11) Expected survival time less than one year
12) Expected poor compliance (e.g. some severe psychiatric disorders, antisocial behaviour, or dementia)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To evaluate cost-effectiveness of various treatment options;Primary end point(s): bladder cancer recurrence rate<br>;Timepoint(s) of evaluation of this end point: 2 years (24 months);Main Objective: 1) To evaluate whether the adjuvant 6-weekly optimized MMC instillation therapy is better than single immediate postoperative instillation therapy in reducing recurrences.<br>2) To evaluate whether the PDD-guided TUR-BT is better than the conventional white light TUR-BT in reducing recurrence, which implies evaluation of whether the effect of PDD-guided TUR-BT is additive to MMC instillation therapy<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - bladder cancer progression rate<br>- treatment failure rate (defined as bladder cancer recurrence, progression or side effects preventing completing the treatment)<br>- mortality rate<br>- Costs (for cost-effectiveness analysis);Timepoint(s) of evaluation of this end point: 2 years (24 months)