Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003824
Status:
TERMINATED
Last Update Posted:
2012-03-09
First Post:
1999-11-01
Brief Title:
S9809 Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
The Effect of Fluoroquinolones on the Disease-Free Interval in Patients With Stage Ta Transitional Cell Carcinoma of the Bladder
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Permanently Closed Due to Poor Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer It is not yet known whether ciprofloxacin is more effective than cephalexin in preventing cancer recurrence in patients who are undergoing surgery to treat bladder cancer
PURPOSE Randomized phase III trial to compare the effectiveness of ciprofloxacin with that of cephalexin in preventing recurrence of cancer in patients who are undergoing surgery for bladder cancer
PURPOSE Randomized phase III trial to compare the effectiveness of ciprofloxacin with that of cephalexin in preventing recurrence of cancer in patients who are undergoing surgery for bladder cancer
Detailed Description:
OBJECTIVES I Determine whether ciprofloxacin improves the recurrence-free survival of patients with superficial transitional cell carcinoma of the bladder treated with a transurethral tumor resection
OUTLINE This is a randomized multicenter study Patients are stratified according to disease status first occurrence vs recurrent disease Patients are randomized to receive either oral ciprofloxacin or oral cephalexin 2 times a day for 3 days starting the night before resection Patients who are allergic to penicillin or a cephalosporin receive oral co-trimoxazole 2 times a day for 3 days All patients undergo complete resection of all bladder tumors Patients are followed every 3 months for the first 2 years every 6 months for the next 2 years and at the end of the fifth year
PROJECTED ACCRUAL A total of 900 patients will be accrued for this study over 3 years
OUTLINE This is a randomized multicenter study Patients are stratified according to disease status first occurrence vs recurrent disease Patients are randomized to receive either oral ciprofloxacin or oral cephalexin 2 times a day for 3 days starting the night before resection Patients who are allergic to penicillin or a cephalosporin receive oral co-trimoxazole 2 times a day for 3 days All patients undergo complete resection of all bladder tumors Patients are followed every 3 months for the first 2 years every 6 months for the next 2 years and at the end of the fifth year
PROJECTED ACCRUAL A total of 900 patients will be accrued for this study over 3 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S9809 | OTHER | None | None |