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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

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Start date: Oct 19, 2023 to Apr 10, 2024 Show 7 more changesShow less
    • Study completion moved earlier from Jun 30, 2034 to Jun 30, 2029
    • Interventions modified
    • Eligibility criteria expanded, about 68 words
    • Secondary endpoints: details revised at 6 of 7 entries
    • Study description expanded, about 131 words
    • Site details revised at 10 of 62 sites
    • Collaborators shortened, about 4 words
  2. Site details revised at 6 of 62 sitesv21
  3. Study sites: 60 to 62v20
  4. 2 versions Re-verified since Jun 16, 2026, no change to tracked fieldsv18-v19
  5. Site details revised at 2 of 60 sitesv17
  6. Trial sites expanded: 39 → 60 locationsv16
  7. 8 versions Re-verified since Sep 15, 2025, no change to tracked fieldsv8-v15
  8. Site details revised at 1 of 39 sitesv7
  9. Study sites: 29 to 39v6
  10. Study sites: 28 to 29v5
  11. Study sites: 20 to 28v4
  12. Study sites: 18 to 20v3
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 18
    • Start date changed from estimate of Dec 19, 2023 to Oct 19, 2023
    v2
  14. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05863195
Lead Sponsor ECOG-ACRIN Cancer Research Group
Conditions
(from sponsor)		 Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver, Stage IV Colorectal Cancer AJCC v8, Unresectable Colorectal Carcinoma
Related terms Colorectal Neoplasms
Enrollment 408 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov