Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for 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.
Drug: gemcitabine hydrochloride
Procedure: adjuvant therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs. Observation After Radical Cystectomy In High-Risk Bladder Cancer|
- Overall survival at 5 years [ Designated as safety issue: No ]
- Disease-free survival at 5 years [ Designated as safety issue: No ]
- Local disease-free survival at 5 years [ Designated as safety issue: No ]
- Distant disease-free survival at 5 years [ Designated as safety issue: No ]
- Toxicity by WHO system grading after each course [ Designated as safety issue: Yes ]
- Quality of life after each course and every 6 months during follow-up [ Designated as safety issue: No ]
- Dose intensity at the end of the treatment [ Designated as safety issue: No ]
|Study Start Date:||September 2001|
|Estimated Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054626
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|Study Chair:||Camillo F. Pollera, MD||Presidio Ospedaliero Belcolle|