Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05863195

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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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 | DecenTrialz