Trial | NCT01801644  Report issue

Title

Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer
Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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 Started
Apr 30
2007
Primary Completion
Jan 31
2013
Study Completion
Feb 28
2013
Last Update
Mar 01
2013
Estimate

Drug gemcitabine plus cisplatin

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

  • Other names: gemzar (gemcitabine) plus cisplatin (= cisplatin)

gemcitabine plus cisplatin Experimental

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

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
No Results Posted