Bladder Cancer Clinical Trial
Official title:
Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs. Observation After Radical Cystectomy In High-Risk Bladder Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. It is not yet known if combination chemotherapy is effective in
preventing relapse in patients who have undergone radical cystectomy for bladder cancer.
PURPOSE: Phase III trial to compare the effectiveness of cisplatin combined with gemcitabine
with that of observation in treating patients with bladder cancer who have undergone surgery
to remove the bladder.
OBJECTIVES:
- Compare the overall, cause-specific, and disease-free survival of patients with
high-risk muscle-invasive transitional cell carcinoma of the bladder treated with
adjuvant cisplatin and gemcitabine vs observation after radical cystectomy.
- Compare the dose intensity and toxicity of two different schedules of cisplatin and
gemcitabine in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and disease status (T2 [G3 only] or T3-4 [any G], N0-2 vs any T, N1-2,
M0). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients are further randomized to 1 of 2 treatment regimens.
- Regimen A: Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1, 8,
and 15.
- Regimen B: Patients receive cisplatin IV on day 15 and gemcitabine as in regimen
A.
Treatment in both regimens repeats every 28 days for 4 courses.
- Arm II: Patients undergo observation followed by cisplatin and gemcitabine as in arm I
at relapse.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 700 patients (350 per treatment arm) will be accrued for this
study within 3 years.
;
Allocation: Randomized, Primary Purpose: Treatment
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