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CardioVascular and Interventional Radiology
Published in: CardioVascular and Interventional Radiology 2/2024

Open Access 09-11-2023 | Systemic Therapy | Study Protocol

Recurrent Colorectal Liver Metastases: Upfront Local Treatment versus Neoadjuvant Systemic Therapy Followed by Local Treatment (COLLISION RELAPSE): Study Protocol of a Phase III Prospective Randomized Controlled Trial

Authors: Madelon Dijkstra, Babette I. Kuiper, Hannah H. Schulz, Susan van der Lei, Robbert S. Puijk, Danielle J. W. Vos, Florentine E. F. Timmer, Hester J. Scheffer, Tineke E. Buffart, M. Petrousjka van den Tol, Birgit I. Lissenberg-Witte, Rutger-Jan Swijnenburg, Kathelijn S. Versteeg, Martijn R. Meijerink, COLLISION Trial Group

Published in: CardioVascular and Interventional Radiology | Issue 2/2024

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Abstract

Purpose

The objective of the COLLISION RELAPSE trial is to prove or disprove superiority of neoadjuvant systemic therapy followed by repeat local treatment (either thermal ablation and/or surgical resection), compared to repeat local treatment alone, in patients with at least one recurrent locally treatable CRLM within one year and no extrahepatic disease.

Methods

A total of 360 patients will be included in this phase III, multicentre randomized controlled trial. The primary endpoint is overall survival. Secondary endpoints are distant progression-free survival, local tumour progression-free survival analysed per patient and per tumour, systemic therapy-related toxicity, procedural morbidity and mortality, length of hospital stay, pain assessment and quality of life, cost-effectiveness ratio and quality-adjusted life years.

Discussion

If the addition of neoadjuvant systemic therapy to repeat local treatment of CRLM proves to be superior compared to repeat local treatment alone, this may lead to a prolonged life expectancy and increased disease-free survival at the cost of possible systemic therapy-related side effects.

Level of Evidence

Level 1, phase III randomized controlled trial.

Trial Registration

NCT05861505. May 17, 2023.

Graphical Abstract

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Metadata
Title
Recurrent Colorectal Liver Metastases: Upfront Local Treatment versus Neoadjuvant Systemic Therapy Followed by Local Treatment (COLLISION RELAPSE): Study Protocol of a Phase III Prospective Randomized Controlled Trial
Authors
Madelon Dijkstra
Babette I. Kuiper
Hannah H. Schulz
Susan van der Lei
Robbert S. Puijk
Danielle J. W. Vos
Florentine E. F. Timmer
Hester J. Scheffer
Tineke E. Buffart
M. Petrousjka van den Tol
Birgit I. Lissenberg-Witte
Rutger-Jan Swijnenburg
Kathelijn S. Versteeg
Martijn R. Meijerink
COLLISION Trial Group
Publication date
09-11-2023
Publisher
Springer US
Published in
CardioVascular and Interventional Radiology / Issue 2/2024
Print ISSN: 0174-1551
Electronic ISSN: 1432-086X
DOI
https://doi.org/10.1007/s00270-023-03602-y

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