TY - JOUR
T1 - Unresectable Intermediate-Size (3–5 cm) Colorectal Liver Metastases
T2 - Stereotactic Ablative Body Radiotherapy Versus Microwave Ablation (COLLISION-XL): Protocol of a Phase II/III Multicentre Randomized Controlled Trial
AU - van der Lei, Susan
AU - Dijkstra, Madelon
AU - Nieuwenhuizen, Sanne
AU - Schulz, Hannah H.
AU - Vos, Danielle J. W.
AU - Versteeg, Kathelijn S.
AU - Buffart, Tineke E.
AU - Swijnenburg, Rutger-Jan
AU - de Vries, Jan J. J.
AU - Bruynzeel, Anna M. E.
AU - van den Tol, M. Petrousjka
AU - Scheffer, Hester J.
AU - Puijk, Robbert S.
AU - Haasbeek, Cornelis J. A.
AU - Meijerink, Martijn R.
AU - and COLLISION Trial Group
AU - Geboers, Bart
AU - Timmer, Floor E. F.
AU - Verheul, Henk
AU - Nielsen, Karin
AU - van der Meijs, Bram
AU - van Grieken, Nicole
AU - van Delden, Otto
AU - van Gulik, Thomas
AU - Besselink, Mark
AU - Tanis, Pieter
AU - van Lienden, Krijn
AU - Burgmans, Mark
AU - van Erkel, Arian
AU - Hartgrink, Henk
AU - van Rijswijk, Carla
AU - Mieog, Sven
AU - Sietses, Colin
AU - van Heek, Tjarda
AU - Diederik, Arjen
AU - Spaargaren, Gert-Jan
AU - Groot, Gerie
AU - Vink, Ted
AU - Manusama, Eric
AU - Eker, Hasan
AU - Dol, Johan
AU - Kappers, Ingrid
AU - van der Leij, Christiaan
AU - Brans, Rutger
AU - Coolsen, Mariëlle
AU - de Jong, Kees
AU - van Dam, Ronald
AU - van Baardewijk, Laurens
AU - Janssen, Jan Jaap
AU - Nijkamp, Maarten
AU - Draaisma, Werner
AU - van den Boezem, Peter
AU - de Wilt, Hans
AU - Torrenga, Hans
AU - Schreurs, Hermien
AU - Smits, Maarten
N1 - Funding Information: The COLLISION-XL trial is a phase II/III, multicentre randomized controlled trial initiated by the Amsterdam University Medical Centres (Amsterdam UMC, location VUmc in Amsterdam, the Netherlands) and endorsed by the Dutch Colorectal Cancer Group (DCCG). Patients will be recruited in at least five hospitals in the Netherlands: Amsterdam UMC (location VUmc), Amsterdam; Ziekenhuis Gelderse Vallei (ZGV), Ede; University Medical Centre Groningen (UMCG), Groningen; Noordwest hospitals, Alkmaar; Medical centre Leeuwarden, Leeuwarden. The trial is investigator-initiated and funded by a partially restricted grant from Johnson & Johnson and registered at clinicaltrials.gov under NCT04081168. The protocol has been approved by the medical Ethical Review Board (METc) of the Amsterdam UMC, location VUmc (no. 2019.262–NL68326.029.19). The trial will be conducted in accordance with the Declaration of Helsinki and the guidelines for Good Clinical Practice (GCP). The duration of the study will be around 4 years (3 years for inclusion and 1 year follow-up). The flow chart of the study design is shown in Fig. . Funding Information: This study is funded by Johnson en Johnson (NW-2021–04). Funding Information: Bart Geboers: AUMC(location VUmc); Floor Timmer: AUMC(location VUmc); Henk Verheul: Radboud UMC; Karin Nielsen: AUMC(location VUmc); BramVan der Meijs: AUMC(location VUmc); Nicole Van Grieken: AUMC(location VUmc); Otto Van Delden: AUMC (location AMC); Thomas Van Gulik: AUMC (location AMC); Mark Besselink: AUMC (location AMC); Pieter Tanis: AUMC (location AMC); Krijn Van Lienden: St. Antonius; Mark Burgmans: LUMC; Arian Van Erkel: LUMC; Henk Hartgrink: LUMC; Carla Van Rijswijk: LUMC; Sven Mieog: LUMC; Colin Sietses: ZGV; Tjarda Van Heek: ZGV; Arjen Diederik: ZGV; Gert-Jan Spaargaren: ZGV; Gerie Groot: ZGV; Ted Vink: MCL; Eric Manusama: MCL; Hasan Eker: MCL; Johan Dol: MCL; Ingrid Kappers: MCL; Christiaan Van der Leij: MUMC; Rutger Brans: MUMC; Mariëlle Coolsen: MUMC; KeesDe Jong: MUMC; Ronald Van Dam: MUMC; Han Kruimer: MMC, Flevoziekenhuis; Laurens Van Baardewijk: MMC; Wouter Leclercq: MMC; Jurgen Futterer: Radboud UMC; Peter Van den Boezem: Radboud UMC; Martijn Stommel: Radboud UMC; Hans De Wilt: Radboud UMC; Sjoerd Jenniskens: Radboud UMC; Mark Arntz: Radboud UMC; Jan Jaap Janssen: Radboud UMC; Hans Torrenga: Deventer MC; Simeon Ruiter: UMCG; Maarten Nijkamp: UMCG; Matthijs Kater: UMCG; Koert De Jong: UMCG; GianPiero Serafino: JBZ; Werner Draaisma: JBZ; Anne Van Geel: NWZ; Hermien Schreurs: NWZ; Maarten Smits: UMCU; Jeroen Hagendoorn: UMCU; Quintus Molenaar: UMCU; Rutger Bruijnen: UMCU; Warner Prevoo: UMCU; Francesco De Cobelli: San Raffaele; Luca Aldrighetti: San Raffaele; Francesca Ratti: San Raffaele; Paolo Marra: San Raffaele; Angelo Della Corte: San Raffaele; Thiery Chapelle: UZA; Marc Peeters: UZA. Publisher Copyright: © 2023, The Author(s).
PY - 2023/8/1
Y1 - 2023/8/1
N2 - 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. Graphical Abstract: [Figure not available: see fulltext.]
AB - 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. Graphical Abstract: [Figure not available: see fulltext.]
KW - Colorectal cancer
KW - Colorectal liver metastases (CRLM)
KW - Liver metastases
KW - Microwave ablation (MWA)
KW - Radiotherapy
KW - Randomized controlled trial (RCT)
KW - Stereotactic body radiotherapy (SBRT)
KW - Thermal ablation
UR - http://www.scopus.com/inward/record.url?scp=85164489106&partnerID=8YFLogxK
U2 - https://doi.org/10.1007/s00270-023-03498-8
DO - https://doi.org/10.1007/s00270-023-03498-8
M3 - Article
C2 - 37430016
SN - 0174-1551
VL - 46
SP - 1076
EP - 1085
JO - Cardiovascular and interventional radiology
JF - Cardiovascular and interventional radiology
IS - 8
ER -