Actively Recruiting
COLDFIRE-III Trial: Efficacy of Irreversible Electroporation and Stereotactic Body Radiotherapy for Perivascular and Peribiliary Colorectal Liver Metastases
Led by Amsterdam UMC, location VUmc · Updated on 2024-08-23
78
Participants Needed
1
Research Sites
366 weeks
Total Duration
On this page
Sponsors
A
Amsterdam UMC, location VUmc
Lead Sponsor
A
Angiodynamics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of this phase IIb/III, prospective, randomized clinical trial is to compare the efficacy of irreversible electroporation (IRE) with stereotactic body radiotherapy (SBRT) in patients with perivascular or peribiliary colorectal liver metastases (CRLM), that are not amenable for surgical resection or thermal ablation. Efficacy is assessed in terms of local control at 2 years.
CONDITIONS
Official Title
COLDFIRE-III Trial: Efficacy of Irreversible Electroporation and Stereotactic Body Radiotherapy for Perivascular and Peribiliary Colorectal Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological confirmation of primary colorectal tumor
- 1-3 colorectal liver metastases (CRLM) visible on CT or MRI, sized 0-5 cm, not suitable for surgery or thermal ablation due to proximity to vessels or bile ducts
- Additional CRLM allowed if resectable or ablatable, up to 10 lesions without extrahepatic disease or up to 5 with limited extrahepatic disease
- No or limited extrahepatic disease; only 1 extrahepatic lesion allowed excluding positive para-aortic or celiac lymph nodes, adrenal metastases, pleural or peritoneal carcinomatosis
- Prior focal liver treatment allowed
- Preferably treated with neo-adjuvant systemic therapy
- Recurrent CRLM after previous focal treatment unsuitable for further systemic therapy
- Adequate bone marrow, liver, and kidney function confirmed by lab tests within 7 days before inclusion
- ASA classification between 0 and 3
- Age over 18 years
- Written informed consent provided
You will not qualify if you...
- Radical treatment considered unfeasible or unsafe (e.g., insufficient future liver remnant)
- More than 10 CRLM lesions or more than 5 CRLM lesions if extrahepatic disease is present
- Presence of positive para-aortic or celiac lymph nodes, adrenal metastases, pleural carcinomatosis, or peritoneal carcinomatosis
- Progressive disease after neo-adjuvant systemic therapy
- History of epilepsy
- History of cardiac disease
- Uncontrolled hypertension with blood pressure above 160/95 mmHg despite stable medication
- Compromised liver function, including signs of portal hypertension, INR above 1.5 without anticoagulants, or ascites
- Pregnant or breastfeeding
- Immunotherapy within 2 weeks before the procedure
- Chemotherapy or targeted therapy within 2 weeks before the procedure
- Severe allergy to contrast media not controlled by premedication
- Any unstable condition that could risk safety or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Amsterdam UMC - location VUmc
Amsterdam, North Holland, Netherlands, 1081 HV
Actively Recruiting
Research Team
D
Danielle J. Vos, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here