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 - COLLISION Trial Group
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 - 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 - Kruimer, Han
AU - De Wilt, Hans
AU - Jenniskens, Sjoerd
AU - Smits, Maarten
N1 - Publisher Copyright: © 2023, The Author(s).
PY - 2023/8
Y1 - 2023/8
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.]
UR - http://www.scopus.com/inward/record.url?scp=85164489106&partnerID=8YFLogxK
U2 - 10.1007/s00270-023-03498-8
DO - 10.1007/s00270-023-03498-8
M3 - Article
C2 - 37430016
AN - SCOPUS:85164489106
SN - 0174-1551
VL - 46
SP - 1076
EP - 1085
JO - CardioVascular and Interventional Radiology
JF - CardioVascular and Interventional Radiology
IS - 8
ER -