University of Iowa Hospitals and Clinics

Clinical Trial Details

Short Title
Official Title
A Phase III Surgical Trial to Evaluate the Benefit of a Standard Versus an Extended Pelvic Lymphadenectomy Performed At Time of Radial Cystectomy For Muscle Invasive Urothelial Cancer
Description

Participants in this research study have bladder cancer (also known as urothelial cancer) that is confined to the bladder but invades into the deep portion of the bladder and requires bladder removal with removal of the lymph nodes in the pelvis.

The purpose of this research study is to compare the effects, good and/or bad, of performing a standard lymph node removal versus an extended lymph node removal at the time that participants are having surgery to remove their bladders. The extended lymph node surgery removes additional lymph nodes that are farther away from the bladder than those removed during standard lymph node surgery. Lymph nodes are present throughout the body and function normally to fight infection. They may also trap cancer cells that spread from a tumor. This is also referred to as metastasis. It is important remove the lymph nodes near the bladder to determine if they contain bladder cancer cells that have spread beyond the bladder. While extended lymph node removal is done commonly at some centers it is still considered experimental since investigators do not know if the additional surgery improves outcome.

Approximately 6 people will take part in this study conducted by investigators at the University of Iowa.

Start Date
May 14, 2013
End Date
May 1, 2015
Gender Preference
None
Age Group
18 - 99 years
Principal Investigator
Daniel Vaena, MD
Contact Info

Clarine Halvorsen, 319-356-3944

Department
Keywords
bladder ; cancer ; IRB#201304744 ; urothelial ; vaena ;

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