Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer
NCT00054626 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700
Last updated 2013-12-18
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.
Conditions
Interventions
- DRUG
- DRUG
-
gemcitabine hydrochloride
- PROCEDURE
-
adjuvant therapy
Sponsors & Collaborators
-
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
lead OTHER_GOV
Principal Investigators
-
Camillo F. Pollera, MD · Presidio Ospedaliero Belcolle
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
Eligibility
- Min Age
- 18 Years
- Max Age
- 74 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-09-30
- Primary Completion
- 2008-06-30
Countries
- Italy
Study Locations
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