About this trial
This trial compares two ways to treat patients with colorectal cancer that has spread to the liver and cannot be removed by surgery. One method includes pump chemotherapy given directly into the liver along with standard treatment. The goal is to see if adding this pump chemotherapy helps patients live longer and improves their overall health.
This is a Phase 3 trial, which means it is looking at how well the treatment works and how safe it is. The trial is regulated by the FDA and aims to include about 408 participants.
Who can join
Adults 18 and older can join if they have been diagnosed with colorectal cancer that has spread to the liver and cannot be surgically removed. They should not have any other cancer spread outside the liver and must have had some prior treatment. The trial team will check to see if each person meets the requirements.
Conditions
Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver, Stage IV Colorectal Cancer AJCC v8, Unresectable Colorectal Carcinoma
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly placed into one of two groups. In the first group, they will have a pump inserted to deliver chemotherapy directly to the liver, along with standard chemotherapy. In the second group, they will receive standard chemotherapy only. Everyone will have regular scans to monitor their progress.
Where
This trial is running at 60 locations in the United States. 58 of them are currently recruiting.
Allegheny General Hospital
Pittsburgh, Pennsylvania
Banner Boswell Medical Center
Sun City, Arizona
Banner MD Anderson Cancer Center
Gilbert, Arizona
Banner-University Medical Center Phoenix
Phoenix, Arizona
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan
Duke Cancer Center Raleigh
Raleigh, North Carolina
Duke University Medical Center
Durham, North Carolina
Emory Saint Joseph's Hospital
Atlanta, Georgia
The first 8 of 60 sites are listed here. The registry record has the full list.