bladder cancer
Conditions
Interventions
IMAGE1 S* + WL assisted TURB (experimental arm) vs WL only assisted TURB
(control arm)
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients scheduled for treatment of a primary or recurrent NMIBC Patients aged 18 years or older Has or has had no tumors in the upper urinary tract Has had no previous irradiation of the pelvis
Exclusion criteria
Exclusion criteria: Gross haematuria at the time of TURB (i.e. heavy bladder bleeding resulting in marked amounts of blood in the urine which may interfere with cystoscopy) Pregnancy or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and are suggested to use the contraceptive pill or an intrauterine device (IUD) during the treatments and for at least one months thereafter) Has had instillation therapy in the six months prior to the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the proportions of Arm A and Arm B subjects that have a histologically confirmed recurrence found at either three months, one year and three years after TURB. | — |
Secondary
| Measure | Time frame |
|---|---|
| Peri-operative morbidity (30 days) assessed by the Clavien-Dindo score Proportion of re-TUR (defined as within 3 months of initial TURB: this can be a planned TURBT because of resection of high risk tumor, or because of recurrent tumor confirmed at cystoscopy at three months) Baseline characteristics of the patients, such as age or BMI Comorbidities, such as Diabetes Mellitus or cardiovascular disease Risk factors, such as smoking and use of anticoagulation When appropriate: information on previous (adjuvant) treatment, such as type and date of most recent treatment and re-TURs | — |
Countries
Netherlands
Outcome results
None listed