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. 2024 Feb;47(2):253-262.
doi: 10.1007/s00270-023-03602-y. Epub 2023 Nov 9.

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

Madelon Dijkstra #  1 , Babette I Kuiper #  2 , Hannah H Schulz  3 , Susan van der Lei  3 , Robbert S Puijk  3 , Danielle J W Vos  3 , Florentine E F Timmer  3 , Hester J Scheffer  3   4 , Tineke E Buffart  5 , M Petrousjka van den Tol  6 , Birgit I Lissenberg-Witte  7 , Rutger-Jan Swijnenburg  2 , Kathelijn S Versteeg #  5 , Martijn R Meijerink #  3 ; COLLISION Trial Group
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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

Madelon Dijkstra et al. Cardiovasc Intervent Radiol. 2024 Feb.

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.

Keywords: Colorectal cancer; Colorectal liver metastases (CRLM); Neoadjuvant systemic therapy; Randomized controlled trial (RCT); Surgery; Thermal ablation.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart of the study design
Fig. 2
Fig. 2
Follow-up scheme
See this image and copyright information in PMC

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