Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer

Study Overview
=================
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).

Official Title
-----------------
Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Drug: gemcitabine plus cisplatin


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gemcitabine plus cisplatin<br>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 | Drug: gemcitabine plus cisplatin<br>* gemcitabine 1000 mg/m2 on days 1,8,15 as a 30 minute infusion followed by cisplatin 70 mg/m2 on day 1 as an 2 hour infusion<br>* Other names: gemzar (gemcitabine) plus cisplatin (= cisplatin);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathologic response rate | evaluation of the pathologic response rate after 3 cycles of neoadjuvant gemcitabine/cisplatin at time of radical cystectomy | at time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety, number of participants with adverse events and grade of adverse events | to assess the safety of neoadjuvant gemcitabine/cisplatin in bladder cancer | adverse events will be evaluated after every 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bladder cancer, neoadjuvant chemotherapy, gem/cis