Bladder Cancer Clinical Trial
Official title:
The Effect of Fluoroquinolones on the Disease-Free Interval in Patients With Stage Ta Transitional Cell Carcinoma of the Bladder
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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