Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
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.
Age
18–74
Sex
ALL
Healthy volunteers
Not accepted