Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial (NCT05863195)
🩺 Plain-English Summary (8th-Grade Level)
This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is already approved by the Food and Drug Administration (FDA) for use in metastatic colorectal cancer to the liver, but it is only available at a small number of hospitals, and most of the time it is not used until standard chemotherapy stops working. Standard chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing unresectable colorectal liver metastases.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (23 items) and avoid the listed exclusions (14 items).
Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patient must not have a liver tumor burden exceeding 70% of total liver volume.
- Patient must not have had prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if completed at least 2 weeks prior to randomization).
- Patient must not have had prior trans-arterial bland embolization, chemoembolization (TACE) or radioembolization (TARE).
- Patient must not have had prior treatment with HAI/floxuridine (FUDR)
- Patient must not have microsatellite instability-high (MSI-H) colorectal cancer.
- Patient must not have CRLM that could be resected with 2-stage hepatectomy, including associating liver partition and portal vein ligation (ALPPS).
- Patient must not have an active infection, serious or non-healing active wound, ulcer, or bone fracture.
- Patient must not have any serious medical problems which would preclude receiving the protocol treatment or would interfere with the cooperation with the requirements of this trial.
- Patient must not have cirrhosis and/or clinical or radiographic evidence of portal hypertension
- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
- All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (62 Sites)
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- Banner-University Medical Center Phoenix — Phoenix, Arizona
- Banner Boswell Medical Center — Sun City, Arizona
- UCHealth University of Colorado Hospital — Aurora, Colorado
- UM Sylvester Comprehensive Cancer Center at Aventura — Aventura, Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida
- UM Sylvester Comprehensive Cancer Center at Hollywood — Hollywood, Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida
- UM Sylvester Comprehensive Cancer Center at Kendall — Miami, Florida
- UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
- Emory Saint Joseph's Hospital — Atlanta, Georgia
- Northwestern University — Chicago, Illinois
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois
- Northwestern Medicine Cancer Center Old Irving Park — Chicago, Illinois
- Memorial Hospital East — Shiloh, Illinois
- IU Health North Hospital — Carmel, Indiana
- Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana
- University of Kentucky/Markey Cancer Center — Lexington, Kentucky
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital — Grand Rapids, Michigan
- University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.