Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT01801644|
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : March 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: gemcitabine plus cisplatin||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||February 2013|
Experimental: gemcitabine plus cisplatin
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
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 Name: gemzar (gemcitabine) plus cisplatin (= cisplatin)
- pathologic response rate [ Time Frame: at time of surgery ]evaluation of the pathologic response rate after 3 cycles of neoadjuvant gemcitabine/cisplatin at time of radical cystectomy
- safety, number of participants with adverse events and grade of adverse events [ Time Frame: adverse events will be evaluated after every 6 months ]to assess the safety of neoadjuvant gemcitabine/cisplatin in bladder cancer
- progression free survival (PFS) [ Time Frame: up to 5 years after including the last patient ]pfs will be assessed avery 3 months in the first year after radical cystectomy, every 6 months in the second year, and yearly from the 3rd year up to a minimum follow up of 5 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801644
|Barmherzige Brüder Vienna|
|Vienna, Austria, 1020|
|Principal Investigator:||Johannes Meran, M.D.||Barmherzige Brüder Vienna|