Actively Recruiting
Led by The Netherlands Cancer Institute · Updated on 2025-03-04
306
Participants Needed
1
Research Sites
260 weeks
Total Duration
Researchers are evaluating a treatment approach for patients with colorectal cancer that has spread to the liver but cannot be surgically removed. This clinical trial compares the combined use of Hepatic Arterial Infusion Pump therapy and systemic chemotherapy against systemic chemotherapy alone to see if the combination improves survival. The study focuses on patients who have not received prior chemotherapy and do not have cancer outside the liver. Participants in the experimental group undergo surgery to implant a pump that delivers the chemotherapy drug Floxuridine directly to the liver, along with systemic chemotherapy given intravenously. The pump treatment cycles last four weeks, while systemic therapies such as FOLFOX or FOLFIRI are administered every two weeks. The control group receives standard systemic chemotherapy without the pump. Both groups have their tumor operability assessed by a specialized liver panel and complete quality of life questionnaires. Throughout the study, patients will have imaging scans including CT angiography and specialized scintigraphy to monitor treatment effects. Researchers will track overall survival for up to five years, along with secondary outcomes like progression-free survival, response rates, surgical complications, and quality of life. Safety and side effects of the therapies are carefully recorded. The total participation time may last several years with regular follow-up visits and evaluations.
CONDITIONS
Induction Treatment for Initially Unresectable Colorectal Liver Metastases: Combined Hepatic Arterial Infusion Pump Therapy With Systemic Therapy
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day for surgery plus up to 2 weeks for immediate post-operative care
Participants in the experimental arm undergo surgery to implant the hepatic arterial infusion pump and resect the primary tumor before starting induction treatment.
1 surgical visit and post-operative monitoring visits
Duration - Up to 6 months of induction treatment
Participants receive induction treatment. Those in the experimental arm receive floxuridine via the hepatic arterial infusion pump every 4 weeks combined with systemic therapy (FOLFOX or FOLFIRI) every 2 weeks. Participants in the control arm receive systemic therapy alone (CAPOX every 3 weeks or FOLFOX/FOLFIRI/FOLFOXIRI every 2 weeks) with optional bevacizumab.
Systemic therapy visits every 2 to 3 weeks; pump therapy every 4 weeks for experimental arm
Duration - Up to 5 years
Participants are monitored for long-term outcomes including survival, disease progression, quality of life, and adverse events up to five years after randomization.
Periodic follow-up visits according to clinical practice
Total: 1 location
1
Antoni van Leeuwenhoek-Netherland Cancer Institute
Amsterdam, Netherlands, 1066CX
Actively Recruiting
K
Koert FD Kuhlmann, MD PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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E M Ter Kuile, Nfm Kok, B Westerink...
https://pubmed.ncbi.nlm.nih.gov/42143303