Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer
- Conditions
- Bladder Cancer
- Registration Number
- NCT00054626
- Lead Sponsor
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 700
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival at 5 years
- Secondary Outcome Measures
Name Time Method Disease-free survival at 5 years Local disease-free survival at 5 years Distant disease-free survival at 5 years Quality of life after each course and every 6 months during follow-up Toxicity by WHO system grading after each course Dose intensity at the end of the treatment
Trial Locations
- Locations (149)
Ospedale Civile Via Caronia
🇮🇹Acireale - CT, Italy
Ospedale S. Giuseppe
🇮🇹Albano, Italy
Ospedale San Lazzaro
🇮🇹Alba, Italy
Ospedale SS. Biagio e Arrigo
🇮🇹Alessandria, Italy
Ospedale Civile Alessandria
🇮🇹Alessandria, Italy
Presidio Ospedale
🇮🇹Anagni, Italy
Istituto Nazionale Riposo e Cura Anziani Istituto
🇮🇹Ancona - AN, Italy
Ospedale Torrette University Ancona
🇮🇹Ancona, Italy
Ospedale Generale Umberto 1
🇮🇹Ancona, Italy
Ospedale S. Donato
🇮🇹Arezzo, Italy
Scroll for more (139 remaining)Ospedale Civile Via Caronia🇮🇹Acireale - CT, Italy