bladder cancer (non-invasive Ta urothelial bladder cancer)
Conditions
Interventions
Product Name: Hexvix
Pharmaceutical Form: Intravesical solution
INN or Proposed INN: hexaminolevulinate
CAS Number: 140898-91-5
Current Sponsor code: Hexvix
Other descriptive name: 5-Aminolevulinic ac
Sponsors
FinnBladder
Eligibility
Sex/Gender
All
Inclusion 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 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
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)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - bladder cancer progression rate - treatment failure rate (defined as bladder cancer recurrence, progression or side effects preventing completing the treatment) - mortality rate - Costs (for cost-effectiveness analysis);Timepoint(s) of evaluation of this end point: 2 years (24 months) | — |
Primary
| Measure | Time frame |
|---|---|
| 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. 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 ;Secondary Objective: To evaluate cost-effectiveness of various treatment options;Primary end point(s): bladder cancer recurrence rate ;Timepoint(s) of evaluation of this end point: 2 years (24 months) | — |
Countries
Finland
Contacts
Public ContactFinnBladder office
FinnBladder
Outcome results
None listed