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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 230

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 with early
arterial phase with 1mm cuts • Adequate bone marrow, liver and renal function
conducted within 15 days prior to inclusion.

Exclusion Criteria

• 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. • 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. • CLM requiring two-staged
resections. • Liver-first resections. • Postoperative radiation of
non-surgically treated (resection or open ablation) CLM • (Partial) portal vein
thrombosis.
• Known DPD-deficiency (heterozygous or homozygous) • Pregnant women or
lactating women.
• History of psychiatric disability judged by the investigator to be clinically
significant, precluding informed consent or interfering with compliance for
HAIP chemotherapy. • 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. • Organ allografts requiring
immunosuppressive therapy.
• Serious, non-healing wound, ulcer, or bone fracture. • Chronic treatment with
corticosteroids (dose of >= 10 mg/day methylprednisolone equivalent excluding
inhaled steroids). • Serious infections (uncontrolled or requiring
treatment). • Participation in another interventional study for CLM with
survival as outcome. • Participation in another prospective study with an
interventional medical product. • 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is progression free survival (PFS). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include OS, PFS in the liver, postoperative complications,<br />adverse events, quality of life, and cost effectiveness. Also, the accuracy of<br />CT angiography to detect extrahepatic perfusion will be evaluated. Next, we aim<br />to identify predictive biomarkers for the efficacy of HAIP chemotherapy.<br />Furthermore, the pharmacokinetic profile of intra-arterial administration of<br />floxuridine will be established.<br /></p>

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