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. 2023 Aug;46(8):1076-1085.
doi: 10.1007/s00270-023-03498-8. Epub 2023 Jul 10.

Unresectable Intermediate-Size (3-5 cm) Colorectal Liver Metastases: Stereotactic Ablative Body Radiotherapy Versus Microwave Ablation (COLLISION-XL): Protocol of a Phase II/III Multicentre Randomized Controlled Trial

Susan van der Lei #  1 , Madelon Dijkstra #  2 , Sanne Nieuwenhuizen  2 , Hannah H Schulz  2 , Danielle J W Vos  2 , Kathelijn S Versteeg  3 , Tineke E Buffart  3 , Rutger-Jan Swijnenburg  4 , Jan J J de Vries  2   5 , Anna M E Bruynzeel  6 , M Petrousjka van den Tol  7 , Hester J Scheffer  2   8 , Robbert S Puijk  2   5 , Cornelis J A Haasbeek  6 , Martijn R Meijerink  2 ; and COLLISION Trial Group
Collaborators, Affiliations

Unresectable Intermediate-Size (3-5 cm) Colorectal Liver Metastases: Stereotactic Ablative Body Radiotherapy Versus Microwave Ablation (COLLISION-XL): Protocol of a Phase II/III Multicentre Randomized Controlled Trial

Susan van der Lei et al. Cardiovasc Intervent Radiol. 2023 Aug.

Abstract

Background: Although microwave ablation (MWA) has a low complication rate and good efficacy for small-size (≤ 3 cm) colorectal liver metastases (CRLM), local control decreases with increasing size. Stereotactic body radiotherapy (SBRT) is gaining interest as a potential means to treat intermediate-size CRLM and might be less susceptible to increasing volume. The objective of this study is to compare the efficacy of MWA to SBRT in patients with unresectable, intermediate-size (3-5 cm) CRLM.

Methods: In this two-arm, multicentre phase II/ III randomized controlled trial, 68 patients with 1-3 unresectable, intermediate-size CRLM suitable for both MWA and SBRT, will be included. Patients will be treated with MWA or SBRT as randomised. The Primary endpoint is local tumour progression-free survival (LTPFS) at 1 year (intention-to-treat analysis). Main secondary endpoints are overall survival, overall and distant progression-free survival (DPFS), local control (LC) and procedural morbidity and mortality and assessment of pain and quality of life.

Discussion: Current guidelines lack clear recommendations for the local treatment of liver only intermediate-size, unresectable CRLM and studies comparing curative intent SBRT and thermal ablation are scarce. Although safety and feasibility to eradicate tumours ≤ 5 cm have been established, both techniques suffer from lower LTPFS and LC rates for larger-size tumours. For the treatment of unresectable intermediate-size CRLM clinical equipoise has been reached. We have designed a two-armed phase II/ III randomized controlled trial directly comparing SBRT to MWA for unresectable CRLM 3-5 cm.

Level of evidence: Level 1, phase II/ III Randomized controlled trial.

Trial registration: NCT04081168, September 9th 2019.

Keywords: Colorectal cancer; Colorectal liver metastases (CRLM); Liver metastases; Microwave ablation (MWA); Radiotherapy; Randomized controlled trial (RCT); Stereotactic body radiotherapy (SBRT); Thermal ablation.

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Conflict of interest statement

M.R. Meijerink has received research grants from Johnson & Johnson. The other authors declare that they have no conflict of interest.

Figures

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

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