An interventional study of gemcitabine plus cisplatin in Bladder Cancer, sponsored by Barmherzige Brüder Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-01.
Sponsored by Barmherzige Brüder Vienna · Not applicable, Interventional, and Treatment
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).
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Barmherzige Brüder Vienna is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Also known as: gemzar (gemcitabine) plus cisplatin (= cisplatin)
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
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
progression free survival (PFS)
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
Time frame: up to 5 years after including the last patient
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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Barmherzige Brüder Vienna