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NCT05863195 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Metastatic Colorectal Carcinoma and Stage IV Colorectal Cancer AJCC v8, sponsored by ECOG-ACRIN Cancer Research Group.

Recruiting
Registry status
Phase 3
Development phase
408
Enrollment target
20
Study locations

NCT05863195 is a Phase 3 study of Metastatic Colorectal Carcinoma and Stage IV Colorectal Cancer AJCC v8 that is actively recruiting participants, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 408 participants, above the 70-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (483% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT05863195, a Phase 3 study of Metastatic Colorectal Carcinoma and Stage IV Colorectal Cancer AJCC v8, is actively recruiting participants, sponsored by ECOG-ACRIN Cancer Research Group.

RECRUITING
Registry status
Phase 3
Development phase
408 participants
Enrollment target
20
Study locations

Study Summary

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 Studied

Metastatic Colorectal Carcinoma Stage IV Colorectal Cancer AJCC v8 Metastatic Malignant Neoplasm in the Liver Unresectable Colorectal Carcinoma

Interventions

  • PROCEDURE Computed Tomography
  • DRUG Fluorouracil
  • BIOLOGICAL Cetuximab
  • BIOLOGICAL Bevacizumab
  • DRUG Floxuridine

Study Locations (20)

Florida

  • UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
  • UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
  • UM Sylvester Comprehensive Cancer Center at Hollywood - Hollywood
  • University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
  • UM Sylvester Comprehensive Cancer Center at Kendall - Miami
  • UM Sylvester Comprehensive Cancer Center at Plantation - Plantation

Illinois

  • University of Chicago Comprehensive Cancer Center - Chicago
  • Memorial Hospital East - Shiloh

Indiana

  • IU Health North Hospital - Carmel
  • Indiana University/Melvin and Bren Simon Cancer Center - Indianapolis

Michigan

  • University of Michigan Comprehensive Cancer Center - Ann Arbor
  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital - Grand Rapids

Missouri

  • Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
  • Siteman Cancer Center at West County Hospital - Creve Coeur

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Colorado

  • UCHealth University of Colorado Hospital - Aurora

Georgia

  • Emory University Hospital/Winship Cancer Institute - Atlanta

Trial Details

FieldValue
Enrollment Target 408 participants
Start Date 2023-10-19
Est. Completion 2034-06-30
Phase Phase 3

Sponsor

ECOG-ACRIN Cancer Research Group

75 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05863195

The ClinicalTrials.gov registry entry for NCT05863195 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 408 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 70-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (483% higher). The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 75 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Metastatic Colorectal Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.

NCT05863195 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, Illinois, Indiana.

Frequently Asked Questions

What is clinical trial NCT05863195 about?

NCT05863195 is a clinical study titled "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 (unre...

What is the current status of trial NCT05863195?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 408 participants. The study started on 2023-10-19. Estimated completion is 2034-06-30.

What conditions does trial NCT05863195 study?

This clinical trial studies the following conditions: Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8, Metastatic Malignant Neoplasm in the Liver, Unresectable Colorectal Carcinoma.

What interventions are being tested in trial NCT05863195?

The interventions under investigation include: Computed Tomography (PROCEDURE), Fluorouracil (DRUG), Cetuximab (BIOLOGICAL), Bevacizumab (BIOLOGICAL), Floxuridine (DRUG).

Who is sponsoring clinical trial NCT05863195?

This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05863195 being conducted?

This trial has 20 study locations across Alabama, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.