COLDFIRE-III Trial: Efficacy of Irreversible Electroporation and Stereotactic Body Radiotherapy for Perivascular and Peribiliary Colorectal Liver Metastases
- Conditions
- Colorectal CancerLiver MetastasesLiver Metastasis Colon CancerUnresectable Solid Tumor
- Registration Number
- NCT06185556
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Histological documentation of primary colorectal tumor is available;<br><br> - 1-3 CRLM visible on ceCT and/or MRI, size 0-5 cm and not eligible for resection or<br> thermal ablation due to location close to a vessel or bile duct;<br><br> - Additional CRLM are allowed if considered either resectable or ablatable with a<br> maximum of 10 CRLM. In patients with extrahepatic disease, a maximum of 5 additional<br> CRLM is allowed;<br><br> - No or limited extrahepatic disease (1 extrahepatic lesion is allowed, with some<br> exclusions mentioned in the exclusion criteria);<br><br> - Prior focal liver treatment is allowed;<br><br> - Subjects should preferably be treated with neo-adjuvant systemic therapy;<br><br> - Subjects with recurrent (either local or distant-hepatic) CRLM after previous focal<br> treatment who are unsuitable for (further) systemic therapy (further downsizing or<br> conversion to resectable disease improbable);<br><br> - Adequate bone marrow, liver and renal function as assessed by laboratory<br> requirements to be conducted within 7 days prior to definite inclusion;<br><br> - ASA classification 0 - 3;<br><br> - Age >18 years;<br><br> - Written informed consent;<br><br>Exclusion Criteria:<br><br> - Radical treatment unfeasible or unsafe (e.g. insufficient FLR);<br><br> - >10 CRLM; >5 CRLM when extra-hepatic disease is present;<br><br> - Positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural<br> carcinomatosis or peritoneal carcinomatosis;<br><br> - Subjects who have progressive disease after neo-adjuvant systemic therapy;<br><br> - History of epilepsy;<br><br> - History of cardiac disease:<br><br> - Uncontrolled hypertension. Blood pressure must be =160/95 mmHg at the time of<br> screening on a stable antihypertensive regimen;<br><br> - Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without use<br> of anticoagulants, ascites);<br><br> - Pregnant or breast-feeding subjects;<br><br> - Immunotherapy = 2 weeks prior to the procedure;<br><br> - Chemotherapy and/or targeted therapy = 2 weeks prior to the procedure;<br><br> - Severe allergy to contrast media not controlled with premedication;<br><br> - Any condition that is unstable or that could jeopardize the safety of the subject<br> and their compliance in the study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Local control
- Secondary Outcome Measures
Name Time Method Overall survival (OS) per patient;Local tumor progression-free survival (LTPFS) per patient and per tumor.;Distant tumor progression-free survival (DPFS) per patient;Time to progression (TTP) per patient;Safety per procedure and per patient;Assessment of pain per patient;Quality of life (QoL) per patient as assessed by EORCT QLQ-C30 questionnaires;Quality of life (QoL) per patient as assessed by EQ-5D questionnaires;Quality of life (QoL) per patient as assessed by PRODISQ questionnaires;Cost-effectiveness ratio (ICER) per patient