Status:
COMPLETED
Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer
Lead Sponsor:
Barmherzige Brüder Vienna
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in locally advanced bladder cancer.
Detailed Description
Patients with locally advanced transitional cell bladder cancer receive 3 cycles of neoadjuvant gemcitabine/cisplatin before radical cystectomy. Patients with histologically confirmed clinical stage ...
Eligibility Criteria
Inclusion
- 18 years of age
- histologically confirmed stage T2, T3 or T4a urothelial bladder cancer with N0-N2
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- bone marrow reserve (neutrophil count \>1500 cells per μL,platelet count \>100 000 per μL) count
- hepatic function (serum bilirubin \<2,5 times the upper limit of normal, serum aminotransferase ≤2,5 times the upper limit of normal).
- renal function with a creatinine clearance \>60ml/min
Exclusion
- metastatic disease
- serious or uncontrolled concurrent medical illness
- pregnancy
- history of other malignancies (with the exception of excised cervical or basal skin or squamous-cell carcinoma)
- non-transitional cell bladder cancer
- creatinine clearance \<60ml/min
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01801644
Start Date
April 1 2007
End Date
February 1 2013
Last Update
March 1 2013
Active Locations (1)
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1
Barmherzige Brüder Vienna
Vienna, Vienna, Austria, 1020