RECRUITINGPhase 2 / Phase 3INTERVENTIONAL
COLDFIRE-III Trial: Efficacy of Irreversible Electroporation and Stereotactic Body Radiotherapy for Perivascular and Peribiliary Colorectal Liver Metastases
COLDFIRE-III Trial: Perivascular and Peribiliary Colorectal Liver Metastases (0-5cm): Irreversible Electroporation Versus Stereotactic Body Radiotherapy
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form;
Who Should NOT Join This Trial:
- 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;
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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 Criteria:
* 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.
Treatments Being Tested
PROCEDURE
Irreversible electroporation
Percutaneous (CT-guided) irreversible electroporation of 1-3 perivascular and peribiliary colorectal liver metastasis.
RADIATION
Stereotactic body radiotherapy
Stereotactic body radiotherapy (CT- or MRI-guided) of 1-3 perivascular and peribiliary colorectal liver metastases.
Locations (1)
Amsterdam UMC - location VUmc
Amsterdam, North Holland, Netherlands