Regional chemotherapy after surgery for colorectal liver metastases - a randomized controlled trial

Phase 1

Active, not recruiting

• Conditions: Patients with resectable colorectal liver metastases; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-001696-21-NL
• Lead Sponsor: Erasmus MC Kanker Instituut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-05
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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 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

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.
• 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).
• Current or recent (within the 28 days prior to randomization) treatment with another investigational drug or participation in another investigational study.
• 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).;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.;Primary end point(s): The primary endpoint is progression free survival (PFS). ;Timepoint(s) of evaluation of this end point: One year after inclusion of the last patient

Secondary Outcome Measures

Name	Time	Method
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