Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs. Observation After Radical Cystectomy In High-Risk Bladder Cancer
- 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,
- Regimen B: Patients receive cisplatin IV on day 15 and gemcitabine as in regimen
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
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
Overall survival at 5 years
Camillo F. Pollera, MD
Presidio Ospedaliero Belcolle
United States: Federal Government