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 compa...
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| Format: | Article |
| Language: | English |
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BMC
2018-08-01
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| Series: | BMC Cancer |
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| Online Access: | http://link.springer.com/article/10.1186/s12885-018-4716-8 |
| _version_ | 1818311785334177792 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Robbert S. Puijk |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-13T08:07:28Z |
| format | Article |
| id | doaj.art-623580f03b0943f3baff8592f6874b61 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-13T08:07:28Z |
| publishDate | 2018-08-01 |
| publisher | BMC |
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| series | BMC Cancer |
| spelling | doaj.art-623580f03b0943f3baff8592f6874b612022-12-21T23:54:17ZengBMCBMC Cancer1471-24072018-08-0118111310.1186/s12885-018-4716-8Colorectal liver metastases: surgery versus thermal ablation (COLLISION) – a phase III single-blind prospective randomized controlled trialRobbert S. Puijk0Alette H. Ruarus1Laurien G. P. H. Vroomen2Aukje A. J. M. van Tilborg3Hester J. Scheffer4Karin Nielsen5Marcus C. de Jong6Jan J. J. de Vries7Babs M. Zonderhuis8Hasan H. Eker9Geert Kazemier10Henk Verheul11Bram B. van der Meijs12Laura van Dam13Natasha Sorgedrager14Veerle M. H. Coupé15Petrousjka M. P. van den Tol16Martijn R. Meijerink17COLLISION Trial GroupDepartment of Radiology and Nuclear Medicine, Amsterdam University Medical Centres (location VUmc)Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centres (location VUmc)Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centres (location VUmc)Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centres (location VUmc)Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centres (location VUmc)Department of Surgery, Amsterdam University Medical Centres (location VUmc)Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centres (location VUmc)Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centres (location VUmc)Department of Surgery, Amsterdam University Medical Centres (location VUmc)Department of Surgery, Amsterdam University Medical Centres (location VUmc)Department of Surgery, Amsterdam University Medical Centres (location VUmc)Department of Medical Oncology, Amsterdam University Medical Centres (location VUmc)Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centres (location VUmc)Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centres (location VUmc)Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centres (location VUmc)Department of Epidemiology and Biostatistics, Amsterdam University Medical Centres (location VUmc)Department of Surgery, Amsterdam University Medical Centres (location VUmc)Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centres (location VUmc)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.http://link.springer.com/article/10.1186/s12885-018-4716-8Colorectal cancerColorectal liver metastases (CRLM)Liver metastasesHepatic resectionLiver surgeryThermal ablation |
| spellingShingle | 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 Colorectal liver metastases: surgery versus thermal ablation (COLLISION) – a phase III single-blind prospective randomized controlled trial BMC Cancer Colorectal cancer Colorectal liver metastases (CRLM) Liver metastases Hepatic resection Liver surgery Thermal ablation |
| 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 | Colorectal cancer Colorectal liver metastases (CRLM) Liver metastases Hepatic resection Liver surgery Thermal ablation |
| url | http://link.springer.com/article/10.1186/s12885-018-4716-8 |
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