Comparing surgical techniques during bladder cancer surgery
A Clinically Integrated Randomized Clinical Trial (RCT) of Modifications to Radical Cystectomy and Postoperative Care
This study is testing two different surgical methods for bladder cancer to see which one helps patients recover better and have fewer complications after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 530 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06703476 on ClinicalTrials.gov |
What this trial studies
This study evaluates two standard surgical techniques used during radical cystectomy for bladder cancer to determine their impact on patient outcomes, such as hospital stay duration and infection rates. Participants will be randomly assigned to receive either a ureteral stent or alvimopan, a drug aimed at promoting bowel function post-surgery. The study aims to clarify the benefits and risks associated with these interventions in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older scheduled for radical cystectomy due to bladder cancer.
Not a fit: Patients on chronic opioid therapy will not benefit from the alvimopan intervention and are excluded from that cohort.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for bladder cancer patients.
How similar studies have performed: Other studies have explored similar surgical techniques, but this specific comparison is novel in its approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: Stent vs. no stent * No exclusion criteria Alvimopan vs. no alvimopan * Patients on chronic opioid therapy are ineligible to receive alvimopan and will be excluded from this cohort of the trial
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering at Basking Ridge (Consent Only) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Consent Only) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Consent Only) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk-Commack (Consent Only) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Consent Only) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Consent Only) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Alvin Goh, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Alvin Goh, MD
- Email: goha@mskcc.org
- Phone: 646-422-4667
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.