TY - JOUR
T1 - Colorectal liver metastases
T2 - Surgery versus thermal ablation (COLLISION) - a phase III single-blind prospective randomized controlled trial
AU - Puijk, Robbert S.
AU - Ruarus, Alette H.
AU - Vroomen, Laurien G.P.H.
AU - van Tilborg, Aukje A.J.M.
AU - Scheffer, Hester J.
AU - Nielsen, Karin
AU - de Jong, Marcus C.
AU - de Vries, Jan J.J.
AU - Zonderhuis, Babs M.
AU - Eker, Hasan H.
AU - Kazemier, Geert
AU - Verheul, Henk
AU - van der Meijs, Bram B.
AU - van Dam, Laura
AU - Sorgedrager, Natasha
AU - Coupé, Veerle M.H.
AU - van den Tol, Petrousjka M.P.
AU - Meijerink, Martijn R.
AU - Prevoo, Warner
AU - Kok, Niels
AU - Diederik, Arjen L.
AU - Spaargaren, Gert Jan
AU - Sietses, Colin
AU - van Heek, Tjarda N.
AU - Serafino, Gian Piero
AU - Futterer, Jurgen J.
AU - van den Boezem, Peter B.
AU - Stommel, Martijn
AU - de Wilt, Hans
AU - Arntz, Mark
AU - Jenniskens, Sjoerd
AU - Besselink, Mark
AU - van Delden, Otto M.
AU - van Gulik, Thomas M.
AU - Tanis, Pieter J.
AU - van Lienden, Krijn P.
AU - Burgmans, Mark C.
AU - Swijnenburg, Rutger Jan
AU - van Erkel, Arian R.
AU - Hartgrink, Henk H.
AU - Peringa, Jan
AU - Marsman, Hendrik
AU - Jacobs, Peter C.A.
AU - Gerhards, Michael F.
AU - van der Leij, Christiaan
AU - Brans, Rutger
AU - Coolsen, Marielle M.E.
AU - Dejong, Kees C.H.C.
AU - van Dam, Ronald
AU - Solouki, Abbas Millad
AU - COLLISION Trial Group
N1 - Funding Information:
Investigator Sponsored Research (ISR) grant by Medtronic PLC. The funders had no role in the design of the study; the collection, analysis, or interpretation of the data; the writing of the manuscript; or the decision to submit the manuscript for publication.
Publisher Copyright:
© 2018 The Author(s).
PY - 2018/8/15
Y1 - 2018/8/15
N2 - 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 (=3cm) will be included to undergo either surgical resection or thermal ablation of appointed target lesion(s) (=3cm). 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 =3cm, 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.
AB - 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 (=3cm) will be included to undergo either surgical resection or thermal ablation of appointed target lesion(s) (=3cm). 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 =3cm, 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.
KW - Colorectal cancer
KW - Colorectal liver metastases (CRLM)
KW - Hepatic resection
KW - Liver metastases
KW - Liver surgery
KW - Microwave ablation (MWA)
KW - Radiofrequency ablation (RFA)
KW - Thermal ablation
UR - https://www.scopus.com/pages/publications/85052066751
U2 - 10.1186/s12885-018-4716-8
DO - 10.1186/s12885-018-4716-8
M3 - Article
SN - 1471-2407
VL - 18
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 821
ER -