Metastases to rectum Trials in Disease

Study on the Effectiveness of Floxuridine in Patients with Resectable Colorectal Liver Metastases and Low Clinical Risk Score

This clinical trial is investigating a specialized approach to treating colorectal cancer that has spread to the liver. The study focuses on patients whose liver metastases can be surgically removed and who have a low clinical risk score, meaning they have a lower chance of the cancer spreading further.

Main inclusion criteria:

• You must be 18 years or older
• You must have an ECOG performance status of 0 or 1, which means you can perform daily activities with little to no limitations
• You must have a Clinical Risk Score (CRS) between 0 and 2
• You must have colorectal cancer confirmed through tissue examination
• Your liver metastases must be suitable for surgical removal or open ablation, as confirmed by imaging tests
• It must be possible to place a catheter for delivering chemotherapy directly to your liver
• Your bone marrow, liver, and kidney function must be adequate, as confirmed by blood tests

Main exclusion criteria:

• You cannot participate if your cancer has spread outside the liver (extrahepatic disease)
• Patients with a clinical risk score above 2 are not eligible
• Patients who are part of vulnerable populations requiring special protection cannot join

Focus and goal of the trial:

The trial aims to compare the effectiveness of surgery combined with hepatic arterial infusion pump (HAIP) chemotherapy to surgery alone. Participants will undergo surgery to remove the liver metastases, and some will receive additional HAIP chemotherapy. This specialized treatment delivers chemotherapy directly to the liver through a pump, allowing higher concentrations of medication to reach the cancer cells while potentially reducing side effects throughout the rest of the body.

The study will monitor several important outcomes, including how long patients live without their cancer getting worse (progression-free survival), overall survival rates, any side effects from treatment, and quality of life. Researchers will also examine how well the chemotherapy is absorbed and processed by the body and evaluate the cost-effectiveness of this approach.

Investigational drug:

The drug being tested is floxuridine, which is delivered through the hepatic arterial infusion pump. Floxuridine is a type of medication that helps stop cancer cells from growing. By delivering it directly to the liver through the hepatic artery, doctors aim to target cancer cells more effectively while minimizing exposure to the rest of the body.

The trial is expected to continue until June 2026 and could provide valuable information about whether adding HAIP chemotherapy to surgery can improve outcomes for patients with this type of cancer.

Summary

Currently, one clinical trial is actively recruiting patients with colorectal cancer that has metastasized to the liver. This trial, conducted in the Netherlands, represents a focused investigation into an innovative treatment approach using hepatic arterial infusion pump chemotherapy with floxuridine. The study specifically targets patients with resectable liver metastases and low clinical risk scores, representing a more favorable patient group. The trial's design comparing surgery with and without HAIP chemotherapy will provide important evidence about whether this targeted drug delivery method offers meaningful benefits over surgery alone. Results from this study could influence future treatment strategies for patients with colorectal liver metastases.