The Society of Interventional Oncology (SIO) has announced the launch of the society’s first clinical trial—Ablation with confirmation of colorectal liver metastases (ACCLAIM) prospective trial for microwave ablation as a local cure. An SIO press release details that this multi-million-dollar trial is funded collectively through grants from Boston Scientific Corporation, NeuWave Medical (part of Ethicon), and Varian, a Siemens Healthineers company.
In this prospective, multicentre, international trial SIO proposes to establish microwave ablation as the preferred treatment option for selected colorectal liver metastases that can be ablated with sufficient margins. The study will be 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 principal investigator for the study. “The ACCLAIM trial could impact patient guidelines with regards to the role of ablation as a treatment option for CRC [colorectal cancer] liver metastases. The study is expected to raise the bar for the standard of care, establishing a reproducible method of achieving tumour ablation with local control,” said Sofocleous. “Clinical research is essential for the continued progress of interventional oncology and SIO will continue to drive such important and focused research efforts.”
Despite a favourable safety profile, historically, the inconsistent local tumour progression (LTP) rates after thermal ablation when compared to surgery have limited the widespread adoption of this treatment option in patients with metastatic colorectal cancer to the liver. Suboptimal outcomes and LTP have been attributed to insufficient coverage of the tumour by the ablation zone (tumour and margins). The ACCLAIM study will estimate disease-free survival of colorectal liver metastases treated with MWA incorporating 3D ablation margin confirmation intraoperatively and through a subsequent independent review centralised validation process.
Matthew Callstrom, professor and department chair of radiology at Mayo Clinic (Rochester, USA) is president of the SIO. “It is important to drive what we do as a field forward together, and it takes collaboration and long-term relationships with our industry partners to enable the right studies to be successful,” said Callstrom. “The ACCLAIM industry partners are raising the bar for research investment by making an important commitment to support societies like SIO. Together, we are advancing our vision to establish interventional oncology as the fourth pillar of cancer therapy.”
Participants of the ACCLAIM trial will be patients with a diagnosis of colorectal cancer liver metastases. MWA will be performed using a US Food and Drug Administration (FDA)-cleared, commercially available MWA system and using margin confirmation (visualisation) software. The ACCLAIM study is set to launch in 2022 with an expected three-year enrolment period of 275 participants across sites in the USA and Europe.