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).
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
No
Johannes Meran, M.D.
Principal Investigator
Barmherzige Brüder Vienna
Austria: Ethikkommission
Bladder Cancer-001
NCT01801644
April 2007
February 2013
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