colorectale levermetastasen Colorectal liver metastases synonyme
Conditions
Interventions
Patients with CRLM who are considered candidates for local therapy, based on
their tumor load, medical history and general health status, but who are not
suitable for resection or thermal ablation d
pulse
length 90µs per pulse
1200-1500V/cm
20-50Ampere
electrode distance 1.5-2.5
cm
active working length 2.0cm) between all electrode pairs (NanoKnife,
Angiodynamics, Latham, NY, USA). After the IRE procedure, additional CRLM can
be resected or treated with RFA or MWA within the s
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Screening must be performed no longer than 4 weeks prior to study inclusion. Subjects are eligible if they meet the following criteria: • Histological or cytological documentation of primary colorectal tumor; • Previous induction chemotherapy due to unresectability; no intra- or extrahepatic disease progression under induction chemotherapy; OR • Previous chemotherapy for other CRLM, now presenting with renewed CRLM unsuitable for resection or thermal ablation; • Liver metastases F-18-FDG PET avid and visible on ceCT, size = 18 years; • ASA classification 0 - 3; • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to definite inclusion: o Hemoglobin >= 5.6 mmol/L; o Absolute neutrophil count (ANC) >= 1,500/mm3; o Platelet count >= 100*109/l; o Total bilirubin
Exclusion criteria
Exclusion criteria: Subjects who meet the following criteria at the time of screening will be excluded: • Lesion > 3,5 cm size; • History of epilepsy; • Extrahepatic metastases rendering local therapy unfeasible; • History of cardiac disease: o Congestive heart failure >NYHA class 2; o Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening); o Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker/ICD (beta blockers are permitted); • Uncontrolled hypertension. Blood pressure must be 1,5 without use of anticoagulants, ascites); • Pregnant or breast-feeding subjects; • Immunotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is efficacy of IRE as expressed in primary technique effectiveness (by perfoming imaging after 3, 6, 9 and 12 months) also expressed by the local IRE site recurrence (LSR) on a per-lesion basis, and secondary technique effectiveness on a per-lesion basis after repeat procedures for local recurrences whenever indicated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are (1) safety, derived from number and grade of (serious) adverse events using the common terminology reporting criteria (CTCAE version 3.0) as recommended by the CIRSE quality approvement guidelines, (2) technical success, defined as the ability to successfully administer all pulses and to have complete tumor coverage on immediate post-IRE imaging (by IOUS or CT) (3) feasibility of cross-sectional imaging modalities to detect local recurrences after IRE, and (4) symptomatic response using specific quality of life questionnaires. | — |
Countries
Netherlands
Outcome results
None listed