Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer

Barmherzige Brüder Vienna60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bladder Cancer

Interventions

gemcitabine plus cisplatinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Barmherzige Brüder Vienna

Vienna, State of Vienna, Austria

Outcomes

Primary Outcomes

pathologic response rate

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

Time frame: at time of surgery

Secondary Outcomes

safety, number of participants with adverse events and grade of adverse events

to assess the safety of neoadjuvant gemcitabine/cisplatin in bladder cancer

Time frame: adverse events will be evaluated after every 6 months

Data from ClinicalTrials.gov

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