Status:
RECRUITING
COLDFIRE-III Trial: Efficacy of Irreversible Electroporation and Stereotactic Body Radiotherapy for Perivascular and Peribiliary Colorectal Liver Metastases
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Angiodynamics, Inc.
Conditions:
Colorectal Cancer
Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 patie...
Detailed Description
Rationale: Currently, the gold standard for perivascular and peribiliary colorectal liver metastases (CRLM), that are not amenable for surgical resection or thermal ablation, is undetermined. Two non-...
Eligibility Criteria
Inclusion
- Histological documentation of primary colorectal tumor is available;
- 1-3 CRLM visible on ceCT and/or MRI, size 0-5 cm and not eligible for resection or thermal ablation due to location close to a vessel or bile duct;
- Additional CRLM are allowed if considered either resectable or ablatable with a maximum of 10 CRLM. In patients with extrahepatic disease, a maximum of 5 additional CRLM is allowed;
- No or limited extrahepatic disease (1 extrahepatic lesion is allowed, with some exclusions mentioned in the exclusion criteria);
- Prior focal liver treatment is allowed;
- Subjects should preferably be treated with neo-adjuvant systemic therapy;
- Subjects with recurrent (either local or distant-hepatic) CRLM after previous focal treatment who are unsuitable for (further) systemic therapy (further downsizing or conversion to resectable disease improbable);
- Adequate bone marrow, liver and renal function as assessed by laboratory requirements to be conducted within 7 days prior to definite inclusion;
- ASA classification 0 - 3;
- Age \>18 years;
- Written informed consent;
Exclusion
- Radical treatment unfeasible or unsafe (e.g. insufficient FLR);
- \>10 CRLM; \>5 CRLM when extra-hepatic disease is present;
- Positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural carcinomatosis or peritoneal carcinomatosis;
- Subjects who have progressive disease after neo-adjuvant systemic therapy;
- History of epilepsy;
- History of cardiac disease:
- Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen;
- Compromised liver function (e.g. signs of portal hypertension, INR \> 1,5 without use of anticoagulants, ascites);
- Pregnant or breast-feeding subjects;
- Immunotherapy ≤ 2 weeks prior to the procedure;
- Chemotherapy and/or targeted therapy ≤ 2 weeks prior to the procedure;
- Severe allergy to contrast media not controlled with premedication;
- Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study.
Key Trial Info
Start Date :
August 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2031
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06185556
Start Date
August 20 2024
End Date
September 1 2031
Last Update
August 23 2024
Active Locations (1)
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1
Amsterdam UMC - location VUmc
Amsterdam, North Holland, Netherlands, 1081 HV