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

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, Warner Prevoo & 31 others Niels Kok, Arjen L. Diederik, Gert Jan Spaargaren, Colin Sietses, Tjarda N. van Heek, Gian Piero Serafino, Jurgen J. Futterer, Peter B. van den Boezem, Martijn Stommel, Hans de Wilt, Mark Arntz, Sjoerd Jenniskens, Mark Besselink, Otto M. van Delden, Thomas M. van Gulik, Pieter J. Tanis, Krijn P. van Lienden, Mark C. Burgmans, Rutger Jan Swijnenburg, Peter C.A. Jacobs, Hans Torrenga, Peter van de Ven, Jacob de Bakker, Martijn W.H. Leenders, Tessa Hellingman, Nicole van Grieken, Sanne Nieuwenhuizen, Bart Geboers, Cornelis van Kuijk, Astrid de Wind, Han Anema

Research output: Contribution to journalArticleAcademicpeer-review

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 (≤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.

LanguageEnglish
Article number821
JournalBMC Cancer
Volume18
Issue number1
DOIs
Publication statusPublished - 15 Aug 2018

Cite this

@article{85ea783070224acfaf860be7dfb09ff6,
title = "Colorectal liver metastases: Surgery versus thermal ablation (COLLISION) - a phase III single-blind prospective randomized controlled trial",
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 (≤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.",
keywords = "Colorectal cancer, Colorectal liver metastases (CRLM), Hepatic resection, Liver metastases, Liver surgery, Microwave ablation (MWA), Radiofrequency ablation (RFA), Thermal ablation",
author = "Puijk, {Robbert S.} and Ruarus, {Alette H.} and Vroomen, {Laurien G.P.H.} and {van Tilborg}, {Aukje A.J.M.} and Scheffer, {Hester J.} and Karin Nielsen and {de Jong}, {Marcus C.} and {de Vries}, {Jan J.J.} and Zonderhuis, {Babs M.} and Eker, {Hasan H.} and Geert Kazemier and Henk Verheul and {van der Meijs}, {Bram B.} and {van Dam}, Laura and Natasha Sorgedrager and Coup{\'e}, {Veerle M.H.} and {van den Tol}, {Petrousjka M.P.} and Meijerink, {Martijn R.} and {COLLISION Trial Group} and Warner Prevoo and Niels Kok and Diederik, {Arjen L.} and Spaargaren, {Gert Jan} and Colin Sietses and {van Heek}, {Tjarda N.} and Serafino, {Gian Piero} and Futterer, {Jurgen J.} and {van den Boezem}, {Peter B.} and Martijn Stommel and {de Wilt}, Hans and Mark Arntz and Sjoerd Jenniskens and Mark Besselink and {van Delden}, {Otto M.} and {van Gulik}, {Thomas M.} and Tanis, {Pieter J.} and {van Lienden}, {Krijn P.} and Burgmans, {Mark C.} and Swijnenburg, {Rutger Jan} and Jacobs, {Peter C.A.} and Hans Torrenga and {van de Ven}, Peter and {de Bakker}, Jacob and Leenders, {Martijn W.H.} and Tessa Hellingman and {van Grieken}, Nicole and Sanne Nieuwenhuizen and Bart Geboers and {van Kuijk}, Cornelis and {de Wind}, Astrid and Han Anema",
year = "2018",
month = "8",
day = "15",
doi = "10.1186/s12885-018-4716-8",
language = "English",
volume = "18",
journal = "BMC Cancer",
issn = "1471-2407",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Colorectal liver metastases

T2 - BMC Cancer

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 - COLLISION Trial Group

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 - Jacobs, Peter C.A.

AU - Torrenga, Hans

AU - van de Ven, Peter

AU - de Bakker, Jacob

AU - Leenders, Martijn W.H.

AU - Hellingman, Tessa

AU - van Grieken, Nicole

AU - Nieuwenhuizen, Sanne

AU - Geboers, Bart

AU - van Kuijk, Cornelis

AU - de Wind, Astrid

AU - Anema, Han

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 - http://www.scopus.com/inward/record.url?scp=85052066751&partnerID=8YFLogxK

U2 - 10.1186/s12885-018-4716-8

DO - 10.1186/s12885-018-4716-8

M3 - Article

VL - 18

JO - BMC Cancer

JF - BMC Cancer

SN - 1471-2407

IS - 1

M1 - 821

ER -