Format

Send to

Choose Destination
BMC Cancer. 2018 Aug 15;18(1):821. doi: 10.1186/s12885-018-4716-8.

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

Author information

1
Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centres (location VUmc), de Boelelaan 1117, 1081, HV, Amsterdam, The Netherlands. r.puijk@vumc.nl.
2
Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centres (location VUmc), de Boelelaan 1117, 1081, HV, Amsterdam, The Netherlands.
3
Department of Surgery, Amsterdam University Medical Centres (location VUmc), de Boelelaan 1117, 1081, HV, Amsterdam, The Netherlands.
4
Department of Medical Oncology, Amsterdam University Medical Centres (location VUmc), de Boelelaan 1117, 1081, HV, Amsterdam, The Netherlands.
5
Department of Epidemiology and Biostatistics, Amsterdam University Medical Centres (location VUmc), de Boelelaan 1117, 1081, HV, Amsterdam, The Netherlands.

Abstract

BACKGROUND:

Radiofrequency 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.

METHODS:

In 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).

DISCUSSION:

If 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 REGISTRATION:

NCT03088150 , January 11th 2017.

KEYWORDS:

Colorectal cancer; Colorectal liver metastases (CRLM); Hepatic resection; Liver metastases; Liver surgery; Microwave ablation (MWA); Radiofrequency ablation (RFA); Thermal ablation

PMID:
30111304
PMCID:
PMC6094448
DOI:
10.1186/s12885-018-4716-8
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for BioMed Central Icon for PubMed Central
Loading ...
Support Center