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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52926

Enrollment

230

Registered

2018-06-05

Start date

2018-08-22

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal liver metastases metastases in the liver of colorectal cancer

Interventions

Resection of CLM, pump placement and adjuvant HAIP chemotherapy.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 (= 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.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is progression free survival (PFS).	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)