Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases in patients with a low clinical risk score - a randomized controlled trial

INTERVENTION: Trade Name: FUDR Product Name: Floxuridine Pharmaceutical Form: Powder for solution for injection/infusion CONDITION: Patients with resectable colorectal liver metastases Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: The primary objective is to compare the efficacy of surgery and adjuvant HAIP chemotherapy to surgery alone in patients with resectable colorectal liver metastases with a low clinical risk score (CRS 0‐2 point). Primary end point(s): The primary endpoint is progression free survival (PFS). Secondary Objective: Secondary objectives are to compare postoperative complications, adverse events, quality of life, and costs between the two arms. Another secondary objective is to determine whether CT angiography can replace a nuclear medicine scan to rule out extrahepatic perfusion of the pump. Next, we aim to identify predictive biomarkers for the efficacy of HAIP chemotherapy and study the pharmacokinetic profile of floxuridine. Timepoint(s) of evaluation of this end point: One year after inclusion of the last patient SECONDARY OUTCOME: Secondary end point(s): Secondary endpoints include OS, PFS in the liver, postoperative complications, adverse events, quality of life, and cost effectiveness. Also, the accuracy of CT angiography to detect extrahepatic perfusion will be evaluated. Next, we aim to identify predictive biomarkers for the efficacy of HAIP chemotherapy. Furthermore, the pharmacokinetic profile of intra‐arterial administration of floxuridine will be established. Timepoint(s) of evaluation of this end point: After inclusion of the last patient, one year after the inclusion of the last patient and 6 years after the inclusion of the last patient INCLUSION CRITERIA: • Age = 18 years. • ECOG performance status 0 or 1. • Clinical Risk Score (CRS) of 0‐2 • Histologically confirmed colorectal cancer (CRC) • Radiologically confirmed CLM amenable for resection or open ablation • Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT excellent arterial phase • Adequate bone marrow, liver and renal function conducted within 15 days prior to inclusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 115 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 115