Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Drug: gemcitabine plus cisplatin

• Registration Number: NCT01801644
• Lead Sponsor: Barmherzige Brüder Vienna

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 T2-T4a, N0-2 bladder cancer are going to be included. After CT scan of the thorax and abdomen plus MRI of the pelvis patient receive chemotherapy.

Pathologic response rate will be assessed after surgery by the institutional pathologic review. Safety is going to be assessed according to the National Cancer Institute Common Toxicity Criteria (CTC,version 3.0).

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2013-01
• Status Verified: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-02-15
• Study First Submitted QC: 2013-02-28
• Last Update Submitted: 2013-02-28
• Study First Posted: 2013-03-01
• Last Update Posted: 2013-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gemcitabine plus cisplatin	gemcitabine plus cisplatin	gemcitabine plus cisplatin: 3 cycles of gemcitabine 1000 mg/m2 on days 1,8,15 as a 30 minute infusion and cisplatin 70 mg/m2 on day 1 as an 2 hour infusion will be applied

Primary Outcome Measures

Name	Time	Method
pathologic response rate	at time of surgery	evaluation of the pathologic response rate after 3 cycles of neoadjuvant gemcitabine/cisplatin at time of radical cystectomy

Secondary Outcome Measures

Name	Time	Method
safety, number of participants with adverse events and grade of adverse events	adverse events will be evaluated after every 6 months	to assess the safety of neoadjuvant gemcitabine/cisplatin in bladder cancer

Trial Locations

Locations (1)

Barmherzige Brüder Vienna; 🇦🇹 Vienna, Austria