Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384891
Status:
TERMINATED
Last Update Posted:
2014-10-07
First Post:
2006-10-05
Brief Title:
Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy BCG for Superficial Bladder Cancer
Sponsor:
Medical Enterprises Europe BV
Organization:
Medical Enterprises Europe BV
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None