Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases - a feasibility study

Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases - a feasibility study - Adjuvant hepatic arterial infusion pump chemotherapy after resection of CLM

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47208

Enrollment

Registered

2017-05-09

Start date

2018-01-11

Completion date

Unknown

Last updated

2024-06-11

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 0-5 • Histologically confirmed colorectal cancer (CRC) • Radiologically confirmed and resectable CLM • Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT or MRI with adequate arterial phase. • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be 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). • Current or recent (within the 28 days prior to inclusion) 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.

Design outcomes

Primary

Measure	Time frame
The primary outcome for safety is the percentage of 90-day postoperative complications (Clavien-Dindo classification, grade III or higher). The primary outcome for feasibility is the percentage of successful administration of at least one cycle of HAIP chemotherapy.	—

Secondary

Measure	Time frame
Secondary outcome are treatment related adverse events grade III or higher (chemotherapy related CTCAE, grade III or higher; appendix D) until 4 weeks after the end of treatment and the accuracy of CT angiography to detect extrahepatic perfusion.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)