A Clinically Integrated Randomized Clinical Trial (RCT) of Modifications to Radical Cystectomy and Postoperative Care

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to look at two standard surgical techniques used during a radical cystectomy and see whether they influence outcomes such as length of stay in the hospital and infections after surgery. This trial will evaluate whether the following surgical methods influence outcomes: A ureteral stent is a thin tube that is placed in the ureter to drain urine from the kidney. Ureteral stents are often used to promote urine drainage after radical cystectomy, but may come at risk of urinary tract infection. Alvimopan is a standard drug used to promote return of bowel function following surgery. Doctors do not know whether alvimopan is beneficial in current clinical practice. The surgeon will decide whether participants will receive a stent and/or alvimopan, but if they are unsure what the best approach is, a surgical technique has been assigned by chance to them.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

⁃ Stent vs. no stent

• Patients aged ≥21 years who are scheduled to undergo radical cystectomy for treatment of bladder cancer with one of the consenting surgeons at MSK Alvimopan vs. no alvimopan

• Patients aged ≥21 years who are scheduled to undergo radical cystectomy for treatment of bladder cancer with one of the consenting surgeons at MSK

Locations
United States
New Jersey
Memorial Sloan Kettering at Basking Ridge (Consent Only)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Consent Only)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Consent Only)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk-Commack (Consent Only)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Consent Only)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
RECRUITING
New York
Memorial Sloan Kettering Nassau (Consent Only)
RECRUITING
Rockville Centre
Contact Information
Primary
Alvin Goh, MD
goha@mskcc.org
646-422-4667
Backup
Bernard Bochner, MD
646-422-4387
Time Frame
Start Date: 2024-11-21
Estimated Completion Date: 2028-11
Participants
Target number of participants: 530
Treatments
Experimental: Stent vs No Stent
For patients treated by a surgeon randomized to use ureteral stents, the operating surgeon may choose to use a single or double J ureteral stent (6- to 8.5-fr in size) or an alternative ureteral stent of the surgeon's choice to be placed across the ureteroenteric anastomosis intraoperatively. Because there is no standard ureteral stent size or type, the surgeon will select a stent type and size according to their experience and will document the stent size and type used. This is already routinely recorded as part of the standard of care at MSK.
Experimental: Alvimopan vs No Alvimopan
For patients randomized to receive alvimopan, the patient will receive alvimopan as a fixed 12-mg dose, with the first dose administered 0.5 to 5 h before the start of surgery; administration will be continued with twice daily oral doses postoperatively until hospital discharge or a maximum of 7 days (15 in-hospital doses), as indicated on the medication's FDA label. This is the current standard of care for most cases at MSK.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov

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