'Colorectal liver metastases' 'Liver Neoplasms / Surgery' 'Infusion pumps' 'Infusions, intra-arterial' Colon cancer with liver metastases
Conditions
Interventions
Patients in the intervention arm will first undergo surgery for pump placement
and resection of the primary tumour. Subsequently, these patients receive
induction therapy with FUDR-HAIP combined wit
Sponsors
Antoni van Leeuwenhoek (AVL)
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Unresectable CRLM (as assessed by liver expert panel) • Resectable primary tumour without indication for neoadjuvant treatment • No previous systemic therapy for colorectal cancer • No extrahepatic metastases • Suitable arterial anatomy for pump placement • Written informed consent
Exclusion criteria
Exclusion criteria: • DPD-deficiency • MMR-deficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival (OS). | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival (PFS), conversion-to-resection rate, R0/R1 resection rate, hepatic progression-free survival (hPFS), radiological response, pathological response, complication rates for pump placement, surgery for the primary tumour and conversion surgery, toxicity of HAIP and systemic therapy, quality of life and cost effectiveness. | — |
Countries
Netherlands
Contacts
Public ContactI P E Tielbeek
Antoni van Leeuwenhoek (AVL)
Outcome results
None listed