Liver metastases tumor growth in the liver
Conditions
Interventions
Liver resection will be carried out within regional centres according to
individual centre protocol. The majority of patients will have undergone
resection of the primary cancer. Patients may be off
Colorectal liver metastases
Liver resection surgery
Thermal ablation
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years 2. Able to provide written informed consent 3. MDT diagnosis of colorectal liver metastases considered to be resectable or ablatable with curative intent 4. Resected colorectal primary or plan for primary resection with curative intent 5. Meets one or more of the following criteria: i) Considered high risk for surgery due to age e.g. age greater than 70 years. ii) Major co-morbidities as judged by the treating clinician. e.g. previous Transient Ischaemic Attack (TIA), major cerebrovascular accidents (CVA), myocardial infarction (MI), severe chronic airway disease, previous pulmonary embolism (PE), chronic kidney disease. iii) Liver metastases with poor prognosis e.g. requiring down staging with chemotherapy prior to definitive treatment, poor response after chemotherapy but still resectable and ablatable, curable extra-hepatic disease , multiple synchronous metastases, previous treated lung metastases (resection or ablation). iv) High risk surgery, e.g. need two staged resection or ALPPS or portal vein embolization, small anticipated remnant liver volume. v) Recurrence of colorectal liver metastases following previous surgery or ablation 6. Suitable candidate for either liver resection surgery or thermal ablation as judged by the MDT 7. Able and willing to comply with the terms of the protocol including QoL questionnaires
Exclusion criteria
Exclusion criteria: 1. Incurable extra-hepatic metastases 2. Not a suitable candidate for liver resection surgery 3. Not a suitable candidate for thermal ablation 4. Concurrent malignant disease (except basal cell carcinoma) 5. Planned simultaneous resection of primary and liver metastases 6. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Disease free survival (measured from randomisation) at 2 years post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| • Overall survival at 2 and 5 years • Local and distant recurrence of disease at 2 years • Disease free survival (measured from end of intervention) at 2 years post-randomisation • Use of subsequent therapies for treatment failure • Health related quality of life (QoL) • Complications during treatment • Post treatment complications • Length of intensive therapy unit (ITU) and inpatient stay • Cost effectiveness (UK only) • Explore the association between tumour markers and recurrence | — |
Countries
The Netherlands
Outcome results
None listed