The Society of Interventional Oncology (SIO) announces the European Institute of Oncology (IEO) in Milan, Italy, as the next European site approved for enrolment and activated for the society’s primary clinical trial, Ablation with Confirmation of Colorectal Liver Metastases (ACCLAIM) prospective trial for microwave ablation as a local cure.
Principal investigator at the study site, Franco Orsi and co-investigator Paolo Della Vigna were recently approved as the eighth site overall, and third European site, activated in the ACCLAIM trial.
In this multicentre, international trial, SIO proposes to establish microwave ablation (MWA) as the preferred treatment option for selected colorectal liver metastases that can be ablated with sufficient margins. The study is the first global, prospective trial to use an objective and reproducible technical outcome in its study design, which SIO believes will drive important changes to future treatment guidelines.
The study will incorporate software to assess the ablation zone and margins and determine if achieving complete margins during an ablation equates to procedural success, where the primary outcome is local disease progression at two-years post-ablation.
Constantinos T Sofocleous (Memorial Sloan Kettering Cancer Center, New York, USA) is the global principal investigator for the study. “We are excited and pleased to share the opening of Orsi’s site,” said Sofocleous. “We look forward to announcing our remaining sites in Europe as they are approved for enrolment to begin.”
Participants of the ACCLAIM trial will be patients with a diagnosis of colorectal cancer liver metastases. MWA will be performed using an FDA-cleared, commercially available MWA system and using margin confirmation (visualisation) software. Upon its launch, the ACCLAIM study is expected to have a three year enrolment period with 330 tumours treated (approximately 275 subjects) across ten sites in the US and Europe.
This trial is funded collectively through grants from Boston Scientific, NeuWave Medical, Varian, and Siemens Healthineers.
