ACCLAIM Trial Completes Enrollment Eight Months Ahead of Schedule for Colorectal Liver Metastases Study
核心洞察
The Society of Interventional Oncology's ACCLAIM Trial successfully enrolled 330 tumors in 240 patients with colorectal liver metastases (搜索) eight months ahead of the enrollment deadline.
This landmark study represents the first global, prospective trial to incorporate objective ablation margin confirmation as a technical endpoint in interventional oncology.
The multi-million-dollar trial involves nine leading cancer centers across the United States and Europe, with funding from Boston Scientific, NeuWave Medical (搜索), and Varian (搜索).
The Society of Interventional Oncology (SIO) has achieved a significant milestone in cancer research by completing enrollment for its landmark ACCLAIM Trial eight months ahead of schedule. The Ablation with Confirmation of Colorectal Liver Metastases (搜索) study successfully enrolled 330 tumors in 240 patients diagnosed with colorectal cancer (搜索) liver metastases, marking a pivotal advancement in interventional oncology research.
Groundbreaking Study Design Sets New Standards
The ACCLAIM Trial represents the first global, prospective study to incorporate an objective and reproducible technical endpoint into its design, establishing a new standard for clinical research in interventional oncology. As the first society-sponsored study in the field, ACCLAIM introduces mandatory ablation margin confirmation as a key component of its methodology.
"For the first time, we are prospectively validating a reproducible technical endpoint - ablation margin confirmation - in a multicenter trial, that not only redefines procedural success but more importantly, improves outcomes for patients with colorectal liver metastases (搜索)," said Constantinos T. Sofocleous, MD, PhD, FSIR, FCIRSE, Professor of Radiology at Weill-Cornell Medical College and Principal Investigator of the ACCLAIM Trial.
Primary Endpoint and Treatment Protocol
The study's primary endpoint estimates the 24-month local tumor progression-free survival of colorectal metastases treated with microwave ablation (MWA) with mandatory ablation margin confirmation. The trial aims to determine whether complete margin coverage during ablation correlates with long-term tumor control, potentially revolutionizing treatment approaches for colorectal liver metastases (搜索).
Tumors were treated using FDA-cleared and/or CE marked microwave ablation systems combined with advanced margin confirmation software, ensuring standardized and reproducible treatment protocols across all participating sites.
Multi-Center Collaboration and Industry Partnership
The multi-million-dollar study represents a pioneering collaboration across the medical device industry, with funding provided through grants from Boston Scientific Corporation, NeuWave Medical (搜索), Inc. (a subsidiary of Ethicon (搜索), Inc.), and Varian (搜索), a Siemens Healthineers (搜索) company.
The trial was conducted across nine leading cancer centers in the United States and Europe, including Amsterdam UMC Cancer Center in the Netherlands, Baptist Health Miami Cancer Institute, European Institute of Oncology in Italy, Lausanne University Hospital and University of Lausanne in Switzerland, Mayo Clinic Rochester, MD Anderson Cancer Center, Medical College of Wisconsin, Memorial Sloan Kettering Cancer Center, and National and Kapodistrian University of Athens in Greece.
Significance for Future Cancer Treatment
"Reaching our enrollment target eight months ahead of schedule reflects the strategic coordination and commitment driving the ACCLAIM Trial - from our dedicated staff to our principal investigators," said Jena Eberly Stack, SIO Executive Director. "From site activation to patient recruitment, this recent milestone showcases what's possible when clinical excellence is matched with a shared commitment to advancing cancer care."
Alexis Kelekis, MD, PhD, EBIR, FCIRSE, FSIR, SIO President and associate professor of interventional radiology at Attikon University Hospital Athens, emphasized the study's broader implications: "As the first society-sponsored study in the field, ACCLAIM sets a new precedent for clinical research. Its success reflects the power of collaboration between leading institutions and industry partners, and it paves the way for more precise, evidence-based approaches to cancer treatment."
The successful completion of enrollment positions the ACCLAIM Trial to provide crucial data on the effectiveness of margin-confirmed microwave ablation for colorectal liver metastases (搜索), potentially establishing new treatment standards in interventional oncology.