Floxuridin for Resectable colorectal liver metastases (no extrahepatic disease)

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- ECOG performance status 0 or 1\n- Clinical Risk Score (CRS) of 0-2\n- Histologically confirmed colorectal cancer (CRC)\n- Radiologically confirmed CLM amenable for resection or open ablation\n- Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT with early arterial phase with 1mm cuts\n- Adequate bone marrow, liver and renal function conducted within 15 days prior to inclusion"}

Exclusion criteria

• {"criterion_text":"- Presence of extrahepatic disease (including positive portal lymph nodes) at the time of liver resection or any time since CRC diagnosis. Patients with small (≤ 1 cm) extrahepatic lesions that are not clearly suspicious of metastases are eligible.\n- History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for HAIP chemotherapy\n- Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator\n- Serious, non-healing wound, ulcer, or bone fracture\n- Organ allografts requiring immunosuppressive therapy\n- Chronic treatment with corticosteroids (dose of ≥ 10 mg/day methylprednisolone equivalent excluding inhaled steroids)\n- Serious infections (uncontrolled or requiring treatment). • Participation in another interventional study for CLM with survival as outcome.\n- Participation in another interventional study for CLM with survival as outcome.\n- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n- Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 5 years previously without evidence of recurrence. • Prior hepatic radiation, resection, or ablation\n- Prior hepatic radiation, resection, or ablation\n- CLM requiring two-staged resections.\n- Liver-first resections\n- Postoperative radiation of non-surgically treated (resection or open ablation) CLM\n- (Partial) portal vein thrombosis\n- Known DPD-deficiency (heterozygous or homozygous)\n- Pregnant women or lactating women"}

Primary endpoints

• {"endpoint_text":"- progression free survival (PFS)","definition_or_measurement_approach":"The primary objective: compare the efficacy of surgery and adjuvant HAIP chemotherapy, assessed by progression free survival (PFS), with surgery alone in patients with resectable colorectal liver metastases with a low clinical risk score (CRS 0-2)."}

Secondary endpoints

• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"To compare overall survival between the two arms."}
• {"endpoint_text":"- Progression free survival in the liver","definition_or_measurement_approach":"To compare progression free survival in the liver between the two arms."}
• {"endpoint_text":"- Postoperative complications","definition_or_measurement_approach":"To compare postoperative complications between the two arms."}
• {"endpoint_text":"- adverse events","definition_or_measurement_approach":"To compare adverse events between the two arms."}
• {"endpoint_text":"- Quality of life","definition_or_measurement_approach":"To compare quality of life between the two arms."}
• {"endpoint_text":"- Cost effectiveness","definition_or_measurement_approach":"To evaluate the cost effectiveness of HAIP chemotherapy expressed by the incremental cost-effectiveness ratio."}
• {"endpoint_text":"- the accuracy of CT angiography to detect extrahepatic perfusion","definition_or_measurement_approach":"To determine whether CT angiography can replace a nuclear medicine scan to rule out extrahepatic perfusion of the pump (assess accuracy to detect extrahepatic perfusion)."}
• {"endpoint_text":"- pharmacokinetic profile of intra-arterial administration of floxuridine will","definition_or_measurement_approach":"To establish the systemic pharmacokinetic profile of intra-arterial administration of floxuridine."}
• {"endpoint_text":"- predictive biomarkers for the efficacy of HAIP chemotherapy","definition_or_measurement_approach":"To identify predictive biomarkers for the efficacy of HAIP chemotherapy."}

Netherlands

Earliest CTIS Part Ii Submission Date

03-10-2024

Latest Decision Or Authorization Date

08-10-2024

Processing Time Days

5

Number Of Sites

13

Number Of Participants

230

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands