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BMC Cancer
Published in: BMC Cancer 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: Robbert S. Puijk, Alette H. Ruarus, Laurien G. P. H. Vroomen, Aukje A. J. M. van Tilborg, Hester J. Scheffer, Karin Nielsen, Marcus C. de Jong, Jan J. J. de Vries, Babs M. Zonderhuis, Hasan H. Eker, Geert Kazemier, Henk Verheul, Bram B. van der Meijs, Laura van Dam, Natasha Sorgedrager, Veerle M. H. Coupé, Petrousjka M. P. van den Tol, Martijn R. Meijerink, COLLISION Trial Group

Published in: BMC Cancer | Issue 1/2018

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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.
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Metadata
Title
Colorectal liver metastases: surgery versus thermal ablation (COLLISION) – a phase III single-blind prospective randomized controlled trial
Authors
Robbert S. Puijk
Alette H. Ruarus
Laurien G. P. H. Vroomen
Aukje A. J. M. van Tilborg
Hester J. Scheffer
Karin Nielsen
Marcus C. de Jong
Jan J. J. de Vries
Babs M. Zonderhuis
Hasan H. Eker
Geert Kazemier
Henk Verheul
Bram B. van der Meijs
Laura van Dam
Natasha Sorgedrager
Veerle M. H. Coupé
Petrousjka M. P. van den Tol
Martijn R. Meijerink
COLLISION Trial Group
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2018
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-018-4716-8

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