Stage IV Bladder Cancer Clinical Trial
Official title:
Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients With pT3-pT4, and/or N+M0 Transitional Cell Carcinoma (TCC) of the Bladder
Randomized phase III trial to compare the effectiveness of immediate adjuvant chemotherapy with that of adjuvant chemotherapy given when the cancer returns in treating patients who have undergone a radical cystectomy for stage III or stage IV transitional cell carcinoma of the bladder urothelium. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known if adjuvant chemotherapy is more effective when given immediately after radical cystectomy (surgery to remove the bladder) or when the cancer returns.
Status | Completed |
Enrollment | 285 |
Est. completion date | July 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC | Arbeitsgemeinschaft Urologische Onkologie, Groupe D'Etude des Tumeurs Uro-Genitales, Institute of Cancer Research, United Kingdom, National Cancer Institute (NCI), NCIC Clinical Trials Group |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of survival | Estimated using the Kaplan-Meier technique and compared based on a two sided logrank test with retrospective stratification for the participating cooperative group, the chemotherapy regimen, the T category and the nodal status. | 5 years | No |
Primary | Duration of progression-free survival | Estimated using the Kaplan-Meier technique and compared based on a two sided logrank test with retrospective stratification for the participating cooperative group, the chemotherapy regimen, the T category and the nodal status. | 5 years | No |
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