Colorectal cancer liver metastases
Conditions
Interventions
Eligible patients will be randomized into one of two arms: arm A (control
group) upfront repeat local treatment and arm B (intervention group) 12 weeks
of neoadjuvant systemic therapy followed by re
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Histological documentation of primary colorectal tumor - Local treatment performed for initial CRLM - >=1 locally treatable recurrent CRLM (partial hepatectomy and/or thermal ablation) - Resection for resectable lesions considered possible obtaining negative resection margins (R0) and preserving adequate liver reserve - Total number of new CRLM
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 objective is to compare overall survival (OS) in both study arms, counting from the date of randomization to the date of death of the patient or to the last day of follow-up (censored). | — |
Secondary
| Measure | Time frame |
|---|---|
| Main secondary endpoints are overall distant progression-free survival (DPFS), local tumor progression-free survival (LTPFS), systemic therapy related toxicity, 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