Colorectal liver metastases: surgery versus thermal ablation (COLLISION) – a phase III single-blind prospective randomized controlled trial

Abstract

BackgroundRadiofrequency ablation (RFA) and microwave ablation (MWA) are widely accepted techniques to eliminate small unresectable colorectal liver metastases (CRLM). Although previous studies labelled thermal ablation inferior to surgical resection, the apparent selection bias when comparing patients with unresectable disease to surgical candidates, the superior safety profile, and the competitive overall survival results for the more recent reports mandate the setup of a randomized controlled trial. The objective of the COLLISION trial is to prove non-inferiority of thermal ablation compared to hepatic resection in patients with at least one resectable and ablatable CRLM and no extrahepatic disease.MethodsIn this two-arm, single-blind multi-center phase-III clinical trial, six hundred and eighteen patients with at least one CRLM (≤3 cm) will be included to undergo either surgical resection or thermal ablation of appointed target lesion(s) (≤3 cm). Primary endpoint is OS (overall survival, intention-to-treat analysis). Main secondary endpoints are overall disease-free survival (DFS), time to progression (TTP), time to local progression (TTLP), primary and assisted technique efficacy (PTE, ATE), procedural morbidity and mortality, length of hospital stay, assessment of pain and quality of life (QoL), cost-effectiveness ratio (ICER) and quality-adjusted life years (QALY).DiscussionIf thermal ablation proves to be non-inferior in treating lesions ≤3 cm, a switch in treatment-method may lead to a reduction of the post-procedural morbidity and mortality, length of hospital stay and incremental costs without compromising oncological outcome for patients with CRLM.Trial registrationNCT03088150, January 11th 2017.

Multidisciplinary management of liver metastases in patients with colorectal cancer: a consensus of SEOM, AEC, SEOR, SERVEI, and SEMNIM

“…There are several ablative technologies available, including heat radiofrequency (RF) or microwaves (MW), cold (cryoablation) or electric pulses (irreversible electroporation [IRE]) [36] ( Table 1). The common factor among ablation therapies is that they are less invasive than surgery, have a shorter recovery time and have fewer major complications [37]. RF, MW ablation, and more recently stereotactic body radiation therapy (SBRT) [38] are ablation therapies with minimal toxicity and good clinical results, providing an opportunity for curative intent to nonoperative patients.…”

Nonresectional regional therapies for metastatic colorectal cancer to the liver

“…[36][37][38] This has inspired an ongoing phase III randomized controlled trial comparing surgical resection to RFA for isolated colorectal liver metastases ≤ 3 cm in size. 39 This study challenges the ideology that surgical resection is the preferred management for isolated hepatic metastases, and mirrors the current treatment approaches to hepatocellular cancer, which have shifted away from surgical management of small tumors.…”

“…Several studies have reported similar recurrence and survival patterns for patients with bilateral or hepatic colorectal metastases who undergo combined surgical resection and RFA compared with surgical resection alone . This has inspired an ongoing phase III randomized controlled trial comparing surgical resection to RFA for isolated colorectal liver metastases ≤ 3 cm in size . This study challenges the ideology that surgical resection is the preferred management for isolated hepatic metastases, and mirrors the current treatment approaches to hepatocellular cancer, which have shifted away from surgical management of small tumors.…”

Thermal Ablation of Metastatic Colon Cancer to the Liver

“…24 Therefore, the ongoing first phase III single blind prospective randomized controlled trial seeking to demonstrate noninferiority of TA compared with hepatic resection for resectable/ablatable CLM is underway. 25 If the trial is successful demonstrating reduced postprocedural morbidity and mortality, reduced length of hospital stay, and potentially decreased costs without compromising oncological outcome, ablation may change the landscape in the management of CLM and in particular for the subgroup of patients with small volume disease that can undergo ablation.…”