Surgery versus thermal ablation for small-size colorectal liver metastases (COLLISION): An international, multicenter, phase III randomized controlled trial
Abstract
LBA3501 Background: The standard of care for local treatment of patients (pts) with colorectal liver metastases (CRLM) is surgical resection. However, growing evidence suggests thermal ablation to be associated with a superior safety profile, lower costs, and shorter hospital stay, while rivaling surgical resection in terms of local control and overall survival (OS). This study aimed to explore the potential non-inferiority of thermal ablation compared to surgical resection for pts with small-size (≤3cm) resectable CRLM. Methods: In this multicenter, phase 3 Dutch Colorectal Cancer Group trial, pts aged 18 years and older with previously untreated CRLM were recruited from 14 centers in the Netherlands, Belgium and Italy. Pts with ≤10 CRLM, no extrahepatic metastases and ECOG 0-2 were stratified into low, intermediate and high disease burden subgroups and randomly assigned (1:1) to undergo surgical resection or thermal ablation. Though approach was left at the discretion of the operator, laparoscopic (+/- robot) resections and percutaneous ablations were favored over open procedures. To avoid drop-outs patients undergoing open procedures were randomized intra-operatively. The primary outcome was overall survival (OS) (log-rank; power 80%, 5% type I error rate; 1-sided). Secondary outcomes include distant and local tumor progression-free survival (PFS), local control, safety, length of hospital stay, quality of life and cost-effectiveness. Results: A total of 341 patients were…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 341 participants or records.
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