Colorectal cancer liver metastases
Conditions
Interventions
Eligible patients will be stratified into low-, intermediate- and high disease
burden after assessment by an expert panel. The panel, consisting of at least
two diagnostic radiologists, two interven
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Histological documentation of primary colorectal tumor; • At least one CRLM size 18 years; • Eastern Cooper ative Oncology Group performance status (ECOG) 0-2; • American Society of Anesthesiologists (ASA) grade 1-3; • Life expectancy of at least 12 weeks; • Written informed consent
Exclusion criteria
Exclusion criteria: • Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment; • Immunotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is OS (intention-to-treat analysis). | — |
Secondary
| Measure | Time frame |
|---|---|
| Main secondary endpoints are overall disease-free survival (DFS), time to progression (TTP), time to local progression (TTLP), primary and assisted technique efficacy (PTE, ATE), procedural morbidity and mortality, length of hospital stay, assessment of pain and quality of life (QoL), cost-effectiveness ratio (ICER) and quality-adjusted life years (QALY). | — |
Countries
Netherlands
Outcome results
None listed