NCT00384891

Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Medical Enterprises Europe B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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

Conditions

• Urinary Bladder Diseases
• Urinary Bladder Neoplasms
• Urinary Bladder Cancer
• Malignant Tumor of Urinary Bladder
• Urologic Diseases
• Urologic Neoplasms
• Neoplasms
• Neoplasms by Site

Interventions

Type	Name	Description
DEVICE	Synergo + MMC	Combined bladder wall hyperthermia and intravesical instillation with cooled Mitomycin-C
DRUG	Bacillus Calmette-Guérin	Intravesical instillation with BCG (Bacillus Calmette-Guérin)

Timeline

• Start date: 2002-02-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2006-10-06
• Last updated: 2014-10-07

Locations

8 sites across 4 countries: Austria, Israel, Italy, Netherlands