International Study on Treatment of Patients With Metastatic Colorectal Liver Lesions Patients With IRE
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAngiodynamics, Inc.
About this trial
Procedural data will be recorded from patients with liver metastases from colorectal cancer who have received at least one course of systemic chemotherapy and who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation.
Eligibility criteria
Qualifiers
Patients aged 18 years and over, able to provide informed consent and with histological confirmation of a diagnosis of colorectal cancer from primary tumour.
Liver lesions demonstrating radiological characteristics (on magnetic resonance scan) of colorectal hepatic metastases without requirement for biopsy. In the setting of an intact liver, patients with up to four metastases ≤ 4cm in size are eligible for inclusion. In the setting of proposed resection plus ablation, up to two metastases ≤ 4cm in size. In the setting of recurrence after prior hepatectomy up to two metastases ≤ 4cm in size.
Eastern Co-operative Oncology Group (ECOG) Score ≤ 2.
Rockwood Frailty Score ≤ 3.
Disqualifiers
Patients involved in other research studies.
Inability to give informed consent.
Patients who are pregnant.
Platelet count < 50x109 U/L.
Trial design
Treatments tested in this trial
- Irreversible Electroporation
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov