Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in locally advanced bladder cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barmherzige Brüder Vienna
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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