NCT05863195 · ECOG-ACRIN Cancer Research Group
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
What this study is about
This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to the usual treatment chemotherapy versus the usual treatment chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable).
View original scientific description
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.
Interventions
BIOLOGICAL
Bevacizumab
Given IV
BIOLOGICAL
Cetuximab
Given IV
PROCEDURE
Computed Tomography
Undergo SPECT/CT and/or CT
DRUG
Floxuridine
Given via HAI pump
DRUG
Fluorouracil
Given IV
PROCEDURE
Implantation
Undergo surgery to place the HAI pump
PROCEDURE
Intrahepatic Infusion Procedure
Undergo HAI
DRUG
Irinotecan
Given IV
DRUG
Leucovorin
Given IV
DRUG
Oxaliplatin
Given IV
BIOLOGICAL
Panitumumab
Given IV
PROCEDURE
Single Photon Emission Computed Tomography
Undergo SPECT/CT
Primary outcome measures
Overall survival (OS)
Time frame: From randomization to death from any cause, assessed up to 5 years
Patients still living will be censored at the date last known alive. OS will be evaluated using the Kaplan-Meier method, and arms will be compared via a stratified log rank test.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient must be \>= 18 years of age
- Patient must have confirmed unresectable liver confined metastatic colorectal cancer (CRC).
- Patient must not have radiographically or clinically evident extrahepatic disease (including but not limited to radiographically positive periportal lymph nodes).
- NOTE: Patients found to have positive periportal nodes at the time of HAI placement can remain on study.
- Patient may have calcified pulmonary nodules, and/or =\< 5 indeterminate and stable (for a minimum of 3 months on chemotherapy) pulmonary nodules each measuring =\< 6 mm in maximal axial dimension.
- Patient's primary tumor may be in place.
- Patient must have received 3-6 months of previous first-line chemotherapy that meet one of the following three criteria: a) have received at least 6 but no more than 12 cycles of first-line cytotoxic chemotherapy (where 1 cycle = 14 days) OR b) have received at least 4 but no more than 8 cycles of first-line cytotoxi
Where
- Birmingham, Alabama
- Gilbert, Arizona
- Phoenix, Arizona
- Sun City, Arizona
- Aurora, Colorado
- Aventura, Florida
- Coral Gables, Florida
- Deerfield Beach, Florida
- Hollywood, Florida
- Miami, Florida
- Plantation, Florida
- Atlanta, Georgia
And 38 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations