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

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 m

Trial Details

NCT ID
NCT05863195
Phase
PHASE3
Sponsor
ECOG-ACRIN Cancer Research Group
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • Bevacizumab
  • Cetuximab
  • Computed Tomography
  • Floxuridine
  • Fluorouracil
  • Implantation
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Aventura, Florida, United States|25.95648,-80.13921
  • Hollywood, Florida, United States|26.0112,-80.14949

Key Eligibility 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 periporta…
  • NOTE: Patients found to have positive periportal nodes at the time of HAI placement can remain on study.

For full eligibility, visit ClinicalTrials.gov.

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