COLLISION RELAPSE Trial
Colorectal Cancer, Liver Metastases, Liver Metastasis Colon Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion criteria Age >18 years Good performance status (ECOG 0-2 // ASA 1-3) Histological documentation of primary colorectal tumor Local treatment performed for initial CRLM New recurrence ≤12 months ≥1 locally treatable CRLM (resectable* and/or ablatable) Total number of new CRLM ≤5 Chemo-naïve or history of response to CAPOX/FOLFOX/FOLRIRI Life expectancy of at least 12 weeks Adequate bone marrow, liver and renal function Written informed consent Exclusion criteria Extrahepatic disease MSI/dMMR Radical local treatment unfeasible or unsafe (e.g. insufficient future liver volume) Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without use of anticoagulants, ascites) Uncontrolled infections (> grade 2 NCI-CTC version 3.0) Pregnant or breast-feeding subjects Immuno- or chemotherapy ≤ 6 weeks prior to the randomization Severe allergy to contrast media not controlled with premedication Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results ECOG = Eastern Cooperative Oncology Group, ASA = American Society of Anesthesiologists, MSI = Microsatellite instability, dMMR = deficient mismatch repair * Resection for resectable lesions considered possible obtaining negative resection margins (R0) and preserving adequate liver reserve
Sites / Locations
- Amsterdam UMCRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Upfront repeat local treatment
Neoadjuvant systemic therapy followed by repeat local treatment