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OncoMatch/Clinical Trials/NCT03216525

Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol

Is NCT03216525 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Alvimopan for bladder cancer.

Phase 3RecruitingBrigham and Women's HospitalNCT03216525Data as of May 2026

Treatment: AlvimopanTo determine if Alvimopan during open or robotic radical cystectomy with urinary diversion results in quicker return of bowel function (GI-2 recovery = time to upper \[first toleration of solid food\] and lower \[first bowel movement\] gastrointestinal recovery) compared to placebo.

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Extracted eligibility criteria

Cancer type

Urothelial Carcinoma

Performance status

ASA 1–4

Prior therapy

Cannot have received: chemotherapy

Exception: prior neoadjuvant chemotherapy allowed if >1 month before surgery

Chemotherapy for bladder cancer within 1 month of scheduled surgery; prior neoadjuvant chemotherapy allowed

Lab requirements

Kidney function

no end-stage renal disease

Liver function

no severe hepatic impairment

Cardiac function

no heart failure

Patients with severe hepatic impairment [excluded]. Patients with end-stage renal disease [excluded]. Patients with heart failure [excluded].

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Brigham and Women's Hospital · Boston, Massachusetts

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