Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium
Stage III Bladder Cancer, Stage IV Bladder Cancer, Transitional Cell Carcinoma of the Bladder
About this trial
This is an interventional treatment trial for Stage III Bladder Cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed transitional cell carcinoma of the bladder urothelium T3-4, N1-3, M0 No pure squamous cell or adenocarcinoma tumors No more than 90 days since prior radical cystectomy and bilateral lymphadenectomy without evidence of microscopic residual disease Performance status - WHO 0-1 WBC at least 3,500/mm^3 Platelet count at least 120,000/mm^3 SGOT/SGPT less than 2.5 times upper limit of normal (ULN) Alkaline phosphatase less than 2.5 times ULN Bilirubin normal Glomerular filtration rate greater than 60 mL/min No clinically significant cardiac arrhythmia No congestive heart failure No complete bundle branch block No New York Heart Association class III or IV heart disease Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after study Considered fit for cisplatin-containing combination chemotherapy No clinically abnormal auditory function No known hypersensitivity to E. coli-derived drug preparations No grade 2 or greater peripheral neuropathy No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix, treated basal cell skin cancer, or treated incidental prostate cancer (pT2, Gleason score no greater than 6, and PSA less than 0.5 ng/mL) No psychological, familial, sociological, or geographical condition that would preclude study involvement No prior systemic chemotherapy No prior radiotherapy to the bladder
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (immediate chemotherapy)
Arm II (deferred chemotherapy)
Beginning within 90 days of radical cystectomy, patients receive a total of 4 courses of adjuvant chemotherapy.
Beginning at the time of clinical relapse, patients receive a total of 6 courses of adjuvant chemotherapy.