Neoplasms Clinical Trial
Official title:
A Randomized Controlled Study Comparing Adjuvant Hyperthermia Treatment in Conjunction With Mitomycin C Versus BCG Immunotherapy (BCG) Adjuvant Treatment in Patients With Superficial Transitional Cell Carcinoma of the Bladder (STCCB)
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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