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.
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
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;
Parallel
Irreversible electroporation
Procedure/SurgeryPercutaneous (CT-guided) irreversible electroporation of 1-3 perivascular and peribiliary colorectal liver metastasis.
Stereotactic body radiotherapy
RadiationStereotactic body radiotherapy (CT- or MRI-guided) of 1-3 perivascular and peribiliary colorectal liver metastases.
Local control
Local control is defined as no objectified signs for local tumor progression on imaging acquired 23-24 months following start of the initial study procedure, according to the RECIST criteria. Site recurrences within the first 12 months that are successfully retreated once using the same technique (re-IRE or re-SBRT), thermal ablation or surgical resection will not be regarded as an event for local control. Per patient analysis.
Overall survival (OS) per patient
Overall survival is defined as the time from randomization to the time of death due to any cause or to the last day of follow up (censored).
Local tumor progression-free survival (LTPFS) per patient and per tumor.
Local tumor progression-free survival is defined as the time from randomization to the time of unequivocal local tumor progression.
Distant tumor progression-free survival (DPFS) per patient
Distant tumor progression-free survival is defined as the time from randomization to the time of unequivocal distant tumor progression.
Time to progression (TTP) per patient
Time to progression is defined as the time from randomization to the time of local disease progression, new metastases (events). The date of death from any cause is considered to be a competing risk
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Amsterdam UMC, location VUmc
Lead sponsor
Angiodynamics, Inc.
Collaborator
