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Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer

18 Years
Not Enrolling
Bladder Cancer

Thank you

Trial Information

Neoadjuvant Gemcitabine and Cisplatin 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).

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pathologic response rate

Outcome Description:

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

Outcome Time Frame:

at time of surgery

Safety Issue:


Principal Investigator

Johannes Meran, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barmherzige Brüder Vienna


Austria: Ethikkommission

Study ID:

Bladder Cancer-001



Start Date:

April 2007

Completion Date:

February 2013

Related Keywords:

  • Bladder Cancer
  • bladder cancer
  • neoadjuvant chemotherapy
  • gem/cis
  • Urinary Bladder Neoplasms