Actively Recruiting
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
Led by ECOG-ACRIN Cancer Research Group · Updated on 2026-05-05
408
Participants Needed
39
Research Sites
558 weeks
Total Duration
On this page
Sponsors
E
ECOG-ACRIN Cancer Research Group
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed colorectal cancer that has spread only to the liver and cannot be removed by surgery
- No visible or clinical evidence of cancer outside the liver except for certain small, stable lung nodules
- May have the original primary tumor still in place
- Received between 3 and 6 months of first-line chemotherapy meeting specific cycle criteria
- Stable or responding disease based on RECIST 1.1 criteria during first-line chemotherapy
- Technical confirmation that surgery to remove liver tumors is not feasible
- Undergo CT angiography to confirm suitable liver artery anatomy and rule out cancer outside the liver within 4 weeks before randomization
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 and clinically fit for surgery
- Adequate blood counts and organ function within 14 days before randomization
- Prior or concurrent malignancies allowed if they do not interfere with treatment evaluation
- HIV-positive patients on effective therapy with undetectable viral load within 6 months allowed
You will not qualify if you...
- Liver tumor burden exceeds 70% of total liver volume
- Prior radiation therapy to the liver
- Previous trans-arterial bland embolization, chemoembolization, or radioembolization treatments
- Prior treatment with hepatic arterial infusion or floxuridine
- Microsatellite instability-high colorectal cancer
- Liver metastases that could be removed by specific two-stage surgical procedures
- Active infection, serious or non-healing wounds, ulcers, or bone fractures
- Serious medical conditions preventing treatment or study participation
- Cirrhosis or evidence of portal hypertension
- Pregnant or breastfeeding women
- Potential to conceive or father children without using effective contraception or abstinence during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
3
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
4
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
5
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
6
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida, United States, 33021
Actively Recruiting
7
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
8
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States, 33176
Actively Recruiting
9
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
10
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
11
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
12
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
13
IU Health North Hospital
Carmel, Indiana, United States, 46032
Actively Recruiting
14
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
15
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
16
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
17
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
18
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
19
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
20
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
21
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
22
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
23
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
24
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
25
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
26
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
27
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
28
Memorial Sloan Kettering Westchester
East White Plains, New York, United States, 10604
Actively Recruiting
29
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
30
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
31
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
32
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
33
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Active, Not Recruiting
34
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
35
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
36
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
37
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
38
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Actively Recruiting
39
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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