This study looks at two common surgical techniques used during surgery for bladder cancer, called radical cystectomy. The goal is to see if these techniques affect how long patients stay in the hospital and the risk of infections after surgery. One technique involves using a ureteral stent, a small tube that helps drain urine but may increase the chance of infections. The other involves using a medication called alvimopan, which helps the bowel function return after surgery. Doctors will assign participants to receive either of these treatments based on chance if they are unsure of the best approach.
The trial's ID number is NCT06703476. This is a Phase 3 trial, which means it is looking at how well the treatments work and how safe they are. The study is regulated by the FDA and aims to include about 530 participants.
Who can join
Anyone aged 21 or older who is scheduled for surgery to treat bladder cancer can join. This trial is open to both men and women. Patients on long-term opioid therapy cannot take alvimopan and will not be eligible for that part of the trial. The trial team will confirm who can participate.
Condition
Bladder Cancer
Age group
Adult, Older adult
Sex
All sexes
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly assigned to one of two groups. In one group, some will receive a ureteral stent placed during surgery, while others will not. In the second group, some participants will receive alvimopan before and after surgery, while others will not receive it. This means everyone gets one of the treatments, but which treatment they get is decided by chance.
Where
This trial is enrolling at 7 locations. Recruiting sites are listed first.
Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey
Recruiting
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey
Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York
Recruiting
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey
Recruiting
Memorial Sloan Kettering Nassau (Consent Only)
Rockville Centre, New York
Recruiting
Memorial Sloan Kettering Suffolk-Commack (Consent Only)
Commack, New York
Recruiting
Memorial Sloan Kettering Westchester (Consent Only)
Medical OncologistMedical Oncologist · New York, NY · New York · NY
Directs translational prostate cancer research, MSK. Treats prostate cancer, bladder cancer, testicular cancer and penile cancer. Works as a genitourinary medical oncologist. Based in New York. Also treats kidney cancer. Chosen on merit.
Medical OncologistMedical Oncologist · New York, NY · New York · NY
Led global trials in liver and bile duct cancer. Treats pancreatic cancer, gallbladder cancer, bile duct cancer and liver cancer. Offers targeted therapy. Works as a gastrointestinal medical oncologist. Based in New York. Chosen on merit.
Medical OncologistMedical Oncologist · Salt Lake City, UT · Utah · UT
Directs genitourinary oncology at Huntsman Cancer Institute. Treats pancreatic cancer, liver cancer, gallbladder cancer and esophageal cancer. Based in Salt Lake City, Utah. Also treats stomach cancer and colorectal cancer. Chosen on merit.