Actively Recruiting
COLDFIRE-III Trial: Irreversible Electroporation Versus Stereotactic Body Radiotherapy for Perivascular and Peribiliary Colorectal Liver Metastases (0-5 cm)
Led by Amsterdam UMC, location VUmc · Updated on 2024-08-23
78
Participants Needed
1
Research Sites
104 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
Researchers are evaluating two non-thermal treatment methods, irreversible electroporation (IRE) and stereotactic body radiotherapy (SBRT), for patients with perivascular or peribiliary colorectal liver metastases (CRLM) that cannot be removed by surgery or treated with thermal ablation. This phase IIb/III randomized clinical trial aims to compare how well these treatments control tumors locally at 2 years. The study also looks at overall survival, safety, pain, quality of life, and treatment costs. Participants will be randomly assigned to receive either IRE or SBRT. IRE is a minimally invasive procedure that uses electrical pulses to destroy tumor cells near important blood vessels and bile ducts while sparing surrounding tissue. SBRT is a precise form of radiation therapy that delivers a high dose to tumors with less damage to nearby healthy tissue. The trial includes 78 patients with 1 to 3 liver metastases sized 0 to 5 cm, and treatment is guided by CT or MRI imaging. An expert panel determines which tumors are suitable for each procedure. During the study, patients will undergo regular assessments including imaging scans to monitor tumor control, survival, and side effects for up to 5 years. Pain levels and quality of life will be measured with questionnaires for up to 1 year. The trial collects data on safety, tumor progression, and cost-effectiveness. Participants are followed closely to evaluate the impact of each treatment over time, with local tumor control at 2 years as the main outcome.
CONDITIONS
Brief 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 to 3 colorectal liver metastases (CRLM) sized 0-5 cm, not eligible for surgery or thermal ablation due to location near vessels or bile ducts
- Additional CRLM allowed if resectable or ablatable, maximum 10 CRLM; for extrahepatic disease, maximum 5 additional CRLM allowed
- No or limited extrahepatic disease (maximum 1 extrahepatic lesion allowed)
- Prior focal liver treatment allowed
- Preferably treated with neo-adjuvant systemic therapy
- Recurrent CRLM unsuitable for further systemic therapy
- Adequate bone marrow, liver, and kidney function within 7 days before inclusion
- ASA classification 0 to 3
- Age over 18 years
- Written informed consent provided
You will not qualify if you...
- Radical treatment unfeasible or unsafe (e.g., insufficient future liver remnant)
- More than 10 CRLM, or more than 5 CRLM if extrahepatic disease present
- Positive para-aortic or celiac lymph nodes, adrenal metastases, pleural or peritoneal carcinomatosis
- Progressive disease after neo-adjuvant systemic therapy
- History of epilepsy
- History of cardiac disease including uncontrolled hypertension (blood pressure ≤160/95 mmHg on stable medication required)
- Compromised liver function (e.g., portal hypertension, INR >1.5 without anticoagulants, ascites)
- Pregnant or breastfeeding
- Immunotherapy within 2 weeks prior to procedure
- Chemotherapy or targeted therapy within 2 weeks prior to procedure
- Severe allergy to contrast media not controlled with premedication
- Any unstable condition that risks safety or compliance in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive either irreversible electroporation (IRE) or stereotactic body radiotherapy (SBRT) for their perivascular or peribiliary colorectal liver metastases.
1 treatment visit (in-person)
Duration - Up to 5 years
Participants are monitored for safety, tumor control, pain, quality of life, and survival outcomes after treatment.
Regular follow-up visits over 5 years
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.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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