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van der Lei, Susan; Dijkstra, Madelon; Nieuwenhuizen, Sanne; Schulz, Hannah H.; Vos, Danielle J. W.; Versteeg, Kathelijn S.; Buffart, Tineke E.; Swijnenburg, Rutger-Jan; de Vries, Jan J. J.; Bruynzeel, Anna M. E.; van den Tol, M. Petrousjka; Scheffer, Hester J.; Puijk, Robbert S.; Haasbeek, Cornelis J. A.; Meijerink, Martijn R.; Geboers, Bart; Timmer, Floor E. F.; Verheul, Henk; Nielsen, Karin; Van der Meijs, Bram; Van Grieken, Nicole; Van Delden, Otto; Van Gulik, Thomas; Besselink, Mark; [...]

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

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  • Medientyp: E-Artikel
  • Titel: 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
  • Beteiligte: van der Lei, Susan; Dijkstra, Madelon; Nieuwenhuizen, Sanne; Schulz, Hannah H.; Vos, Danielle J. W.; Versteeg, Kathelijn S.; Buffart, Tineke E.; Swijnenburg, Rutger-Jan; de Vries, Jan J. J.; Bruynzeel, Anna M. E.; van den Tol, M. Petrousjka; Scheffer, Hester J.; Puijk, Robbert S.; Haasbeek, Cornelis J. A.; Meijerink, Martijn R.; Geboers, Bart; Timmer, Floor E. F.; Verheul, Henk; Nielsen, Karin; Van der Meijs, Bram; Van Grieken, Nicole; Van Delden, Otto; Van Gulik, Thomas; Besselink, Mark; [...]
  • Erschienen: Springer Science and Business Media LLC, 2023
  • Erschienen in: CardioVascular and Interventional Radiology
  • Sprache: Englisch
  • DOI: 10.1007/s00270-023-03498-8
  • ISSN: 0174-1551; 1432-086X
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Discussion</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title> <jats:italic>Level of Evidence</jats:italic> </jats:title> <jats:p>Level 1, phase II/ III Randomized controlled trial.</jats:p> <jats:p><jats:italic>Trial Registration</jats:italic>: NCT04081168, September 9th 2019.</jats:p> </jats:sec><jats:sec> <jats:title>Graphical Abstract</jats:title> </jats:sec>