Clinical trial · Interventional
Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC
The ILEUS Study: A Phase 2 Randomized Controlled Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): stopped by sponsor
Summary
Brief summary (as posted)
The purpose of this study is to investigate the ability of alvimopan to reduce the time to return of bowel function in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Half of the participants will receive alvimopan or and half will receive placebo immediately before and for up to seven days after surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ileus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alvimopan | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Alvimopan
- description
- alvimopan 12 mg PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge
- interventionNames
- Drug: Alvimopan
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo pill PO twice daily, starting POD 1 for the earlier of 7 days or hospital discharge
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Time to Return of Upper and Lower GI Function
- timeFrame
- from surgery to discharge (generally no longer than two weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent. * Scheduled to undergo open (non-minimally invasive) CRS/HIPEC. * Scheduled to receive postoperative pain management with intravenous opioids. * Age \> 18 years. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2. * Women of child-bearing potential with negative pregnancy test prior to initiating study drug dosing. Exclusion Criteria: * Greater than 7 days of consecutive opioid use immediately prior to scheduled surgery. * Child-Pugh Class C hepatic impairment. * End-stage renal disease (GFR \< 15 mL/min/1.73 m2 and/or on peritoneal dialysis or hemodialysis). * Complete mechanical bowel obstruction. * Contraindication or inability to tolerate oral medication postoperatively. * Presence of gastrointestinal ostomy after CRS/HIPEC. * Pancreatic or gastric anastomosis performed during CRS/HIPEC. * History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition as alvimopan at the treating investigators discretion. * Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e. uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements). * History of myocardial infarction in the 12 months prior to scheduled surgery. * Pregnant or nursing.
References
Publications (1)
- DERIVEDBaumgartner JM, Chen R, Messer K, Veerapong J, Kelly KJ, Ramamoorthy S, Lowy AM. Alvimopan for Enhanced Gastrointestinal Recovery after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: A Randomized Controlled Trial. J Am Coll Surg. 2022 Nov 1;235(5):693-701. doi: 10.1097/XCS.0000000000000305. Epub 2022 Oct 17. PMID 36102565