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

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 pat...

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Autores principales: Puijk, Robbert S., Ruarus, Alette H., Vroomen, Laurien G. P. H., van Tilborg, Aukje A. J. M., Scheffer, Hester J., Nielsen, Karin, de Jong, Marcus C., de Vries, Jan J. J., Zonderhuis, Babs M., Eker, Hasan H., Kazemier, Geert, Verheul, Henk, van der Meijs, Bram B., van Dam, Laura, Sorgedrager, Natasha, Coupé, Veerle M. H., van den Tol, Petrousjka M. P., Meijerink, Martijn R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6094448/
https://www.ncbi.nlm.nih.gov/pubmed/30111304
http://dx.doi.org/10.1186/s12885-018-4716-8
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author Puijk, Robbert S.
Ruarus, Alette H.
Vroomen, Laurien G. P. H.
van Tilborg, Aukje A. J. M.
Scheffer, Hester J.
Nielsen, Karin
de Jong, Marcus C.
de Vries, Jan J. J.
Zonderhuis, Babs M.
Eker, Hasan H.
Kazemier, Geert
Verheul, Henk
van der Meijs, Bram B.
van Dam, Laura
Sorgedrager, Natasha
Coupé, Veerle M. H.
van den Tol, Petrousjka M. P.
Meijerink, Martijn R.
author_facet Puijk, Robbert S.
Ruarus, Alette H.
Vroomen, Laurien G. P. H.
van Tilborg, Aukje A. J. M.
Scheffer, Hester J.
Nielsen, Karin
de Jong, Marcus C.
de Vries, Jan J. J.
Zonderhuis, Babs M.
Eker, Hasan H.
Kazemier, Geert
Verheul, Henk
van der Meijs, Bram B.
van Dam, Laura
Sorgedrager, Natasha
Coupé, Veerle M. H.
van den Tol, Petrousjka M. P.
Meijerink, Martijn R.
author_sort Puijk, Robbert S.
collection PubMed
description 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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spelling pubmed-60944482018-08-20 Colorectal liver metastases: surgery versus thermal ablation (COLLISION) – a phase III single-blind prospective randomized controlled trial Puijk, Robbert S. Ruarus, Alette H. Vroomen, Laurien G. P. H. van Tilborg, Aukje A. J. M. Scheffer, Hester J. Nielsen, Karin de Jong, Marcus C. de Vries, Jan J. J. Zonderhuis, Babs M. Eker, Hasan H. Kazemier, Geert Verheul, Henk van der Meijs, Bram B. van Dam, Laura Sorgedrager, Natasha Coupé, Veerle M. H. van den Tol, Petrousjka M. P. Meijerink, Martijn R. BMC Cancer Study Protocol 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. BioMed Central 2018-08-15 /pmc/articles/PMC6094448/ /pubmed/30111304 http://dx.doi.org/10.1186/s12885-018-4716-8 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Puijk, Robbert S.
Ruarus, Alette H.
Vroomen, Laurien G. P. H.
van Tilborg, Aukje A. J. M.
Scheffer, Hester J.
Nielsen, Karin
de Jong, Marcus C.
de Vries, Jan J. J.
Zonderhuis, Babs M.
Eker, Hasan H.
Kazemier, Geert
Verheul, Henk
van der Meijs, Bram B.
van Dam, Laura
Sorgedrager, Natasha
Coupé, Veerle M. H.
van den Tol, Petrousjka M. P.
Meijerink, Martijn R.
Colorectal liver metastases: surgery versus thermal ablation (COLLISION) – a phase III single-blind prospective randomized controlled trial
title Colorectal liver metastases: surgery versus thermal ablation (COLLISION) – a phase III single-blind prospective randomized controlled trial
title_full Colorectal liver metastases: surgery versus thermal ablation (COLLISION) – a phase III single-blind prospective randomized controlled trial
title_fullStr Colorectal liver metastases: surgery versus thermal ablation (COLLISION) – a phase III single-blind prospective randomized controlled trial
title_full_unstemmed Colorectal liver metastases: surgery versus thermal ablation (COLLISION) – a phase III single-blind prospective randomized controlled trial
title_short Colorectal liver metastases: surgery versus thermal ablation (COLLISION) – a phase III single-blind prospective randomized controlled trial
title_sort colorectal liver metastases: surgery versus thermal ablation (collision) – a phase iii single-blind prospective randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6094448/
https://www.ncbi.nlm.nih.gov/pubmed/30111304
http://dx.doi.org/10.1186/s12885-018-4716-8
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