Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042887
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
2002-08-05
Brief Title:
Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Chemoresection With 4 Weekly Intravesical Instillations Of Mitomycin C Versus Transurethral Resection TUR Followed By One Single Immediate Instillation Of Mitomycin C In Single Small Papillary Stage Ta T1 Bladder Tumors A Prospective Randomized Phase III Trial
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Infusing chemotherapy drugs directly into the bladder may kill more cancer cells It is not yet known if surgery followed by chemotherapy is more effective than chemotherapy alone in treating bladder cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy alone with that of transurethral resection followed by chemotherapy in treating patients who have bladder cancer
PURPOSE Randomized phase III trial to compare the effectiveness of chemotherapy alone with that of transurethral resection followed by chemotherapy in treating patients who have bladder cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of chemoresection with 4 weekly intravesical instillations of mitomycin vs transurethral resection followed by 1 instillation of mitomycin in patients with low-risk superficial transitional cell carcinoma of the bladder
Compare the disease-free survival of patients treated with these regimens
Determine the response rate at 6 weeks in patients treated with chemoresection
Determine the percent of patients with tumor at 6 weeks treated with transurethral resection
Compare the quality of life of patients treated with these regimens
Compare the side effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease status primary vs recurrent and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo chemoresection with intravesical instillation of mitomycin once weekly for 4 weeks
Arm II Patients undergo transurethral resection followed within 1-6 hours by intravesical instillation of mitomycin
Quality of life is assessed at baseline at week 1 arm II only at week 5 arm I only and then at week 6
Patients are followed at weeks 6 and 19 every 6 months for 3 years and then annually for 2 years
PROJECTED ACCRUAL A total of 1000 patients 500 per treatment arm will be accrued for this study within 5 years
Compare the efficacy of chemoresection with 4 weekly intravesical instillations of mitomycin vs transurethral resection followed by 1 instillation of mitomycin in patients with low-risk superficial transitional cell carcinoma of the bladder
Compare the disease-free survival of patients treated with these regimens
Determine the response rate at 6 weeks in patients treated with chemoresection
Determine the percent of patients with tumor at 6 weeks treated with transurethral resection
Compare the quality of life of patients treated with these regimens
Compare the side effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease status primary vs recurrent and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo chemoresection with intravesical instillation of mitomycin once weekly for 4 weeks
Arm II Patients undergo transurethral resection followed within 1-6 hours by intravesical instillation of mitomycin
Quality of life is assessed at baseline at week 1 arm II only at week 5 arm I only and then at week 6
Patients are followed at weeks 6 and 19 every 6 months for 3 years and then annually for 2 years
PROJECTED ACCRUAL A total of 1000 patients 500 per treatment arm will be accrued for this study within 5 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-30004 | None | None | None |