NCT01801644

Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer

Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Barmherzige Brüder Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in locally advanced bladder cancer.

Detailed description

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).

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-04-01
• Primary completion: 2013-01-01
• Completion: 2013-02-01
• First posted: 2013-03-01
• Last updated: 2013-03-01

Locations

1 site across 1 country: Austria