The study is designed to compare the efficacy and safety of 2 treatment types for the prevention of tumor recurrence of superficial bladder cancer: 1. A combination of bladder wall heating and local chemotherapy (Synergo) 2. Bacillus Calmette-Guérin (BCG)
The study is a randomized controlled study, designed to test the efficacy and safety of a new treatment modality for the prevention of tumor recurrence in superficial bladder cancer. Patients must have their tumors surgically resected prior to study enrollment, and undergo a series of tests to prove their bladder is now free of tumor. Eligible patients will be randomly assigned to one of 2 treatment arms: 1. A combination of bladder wall heating and local chemotherapy (Synergo) 2. Bacillus Calmette-Guérin (BCG) Patients will be treated during the first year of the study, and will be followed up for a total of 2 years. The follow up will include a visual evaluation of the patient's bladder by cystoscopy, a cytological examination of the urine (to look for malignant cells) and other additional exams. The patients' general welfare will be monitored through out the study. The aim of this study is to compare the efficacy and safety of the novel treatment (Synergo) to that of the well-known BCG
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
Intravesical instillation with BCG (Bacillus Calmette-Guérin)
University Hospital - AKH Vienna
Vienna, Austria
Bnai Zion Medical Center
Haifa, Israel
Wolfson Hospital
Holon, Israel
Hadassah University Hospital
Jerusalem, Israel
Galliera Hospital
Genova, Italy
Istituto Europeo del Oncologia
Milan, Italy
San Raffaele Hospital (HSR)
Milan, Italy
Department of Urology, Radboud University Hospital
Nijmegen, Netherlands
Recurrence free survival
Recurrence free survival probability of STCCB in patients with pure (non-CIS) papillary tumor
Time frame: 2 years
Proportion of complete response in CIS patients
Time frame: 3 months
Progression rate (to disease stage>T1) and/or metastatic disease
Time frame: 2 years
Local and systemic side effects, both subjective and objective
Time frame: 2 years
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